Roche Operations L T D

FDA Filings

This page includes the latest FDA filings for Roche Operations L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2627723
• FEI Number: 2627723
• Name: Roche Operations, Ltd.
• Owner & Operator: Roche Diagnostics Operations Inc.
• Contact Address: 9115 Hague Road ; Indianapolis IN 46250 US
• Official Correspondent:
  • Michael Leslie
  • x-317-5214343-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2875 Ponce By-Pass, PO Box 7085 ; Ponce, PR 00732 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	LABELED VIAL A/C PERFORMA 10CT STRIP	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	LABELED VIAL A/C AVIVA 10CT STRIP	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	LABELED VIAL A/C AVIVA 10CT STRIP DE	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	Accu-Chek Guide Blood Glucose Monitoring System	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK ST STRIP 50CT JAPAN	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIPS EURO 6	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP TK BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP NON EU	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP LA	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP EURO5	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP EURO4	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP EURO3	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP EURO1	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP CHINA BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP BALTIC BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50CT STRIP AR	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 50 STRIP AGENCIES BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 10CT STRIPS EURO 6	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 10CT STRIP NON EU	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 10CT STRIP EURO5	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 10CT STRIP EURO4	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 10CT STRIP EURO3	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 10CT STRIP EURO1	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 10CT STRIP BALTIC BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK PERFORMA 100CT STRIP RU	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP TR	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP NON EU2	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP NON EU1	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP EURO6	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP EURO5	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP EURO4	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP EURO2	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP EURO1	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP EURO 3	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 50CT STRIP APAC	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 25CT STRIP NON EU	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 25CT STRIP EURO	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 25CT STRIP APAC	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 10CT STRIPS NON EU	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 10CT STRIP EURO	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 10CT STRIP APAC	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 100CT STRIP PL	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 100CT STRIP EURO	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INSTANT 100CT STRIP APAC	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INFORM II NON-EU LA STRIP	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INFORM II CA 50CT 10/CS F2	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK INFORM II APAC	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 50CT USO AR	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 50CT LATAM	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 50CT EU3	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 50CT EU 5	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 50CT EU 4	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 50CT CHINA	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 30CT JAPAN	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 25CT LATAM	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 25CT JAPAN	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 25CT CHINA	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 10CT LATAM	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 10CT EU3	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 100CT USO AR	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 100CT EU 1	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK GUIDE TEST STRIP 100CT CHINA	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA STRIPS UK 50 BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA STRIPS SPAIN 50 BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA STRIPS GERMANY 50 BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA STRIPS EURO 50 BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA STRIPS EURO 25 BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA STRIPS EURO 100 BRK	2017-01-26
LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA STRIPS CA 100 BRK	2017-01-26
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Test Strip	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Blood Glucose Monitoring System	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Meter	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Control Solutions	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Combo System	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA SMPL KIT BRK 16/CS	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA RETAIL KIT BRK 8/CS	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS METER ONLY BRK	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 10CT STRIP BRK	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C	2016-10-14
PMN K131029 | NDC Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA HNP KIT BRK 8/CS	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Test Strip	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Blood Glucose Monitoring System	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Meter	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Control Solutions	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Combo System	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA SMPL KIT BRK 16/CS	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA RETAIL KIT BRK 8/CS	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS METER ONLY BRK	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 10CT STRIP BRK	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C	2016-10-14
PMN K131029 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA HNP KIT BRK 8/CS	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Test Strip	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Blood Glucose Monitoring System	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Meter	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Control Solutions	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Combo System	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA SMPL KIT BRK 16/CS	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA RETAIL KIT BRK 8/CS	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS METER ONLY BRK	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 10CT STRIP BRK	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C	2016-10-14
PMN K131029 | LZG Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA HNP KIT BRK 8/CS	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Test Strip	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Plus Blood Glucose Monitoring System	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Meter	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Control Solutions	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva Combo System	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA SMPL KIT BRK 16/CS	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA RETAIL KIT BRK 8/CS	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS METER ONLY BRK	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50CT STRIP BRK 36/C	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MLRDR BRK 36/CS	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 MED-BEN BRK 36/C	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 50 HN STP BRK 36/CS	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 10CT STRIP BRK	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA PLUS 100CT STRP BRK 24/C	2016-10-14
PMN K131029 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA HNP KIT BRK 8/CS	2016-10-14
PMN K043474 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK LINEARITY TEST KIT	2016-10-13
PMN K043474 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva System	2016-10-13
PMN K043474 | NBW Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA MG/DL	2016-10-13
PMN K043474 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK LINEARITY TEST KIT	2016-10-13
PMN K043474 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva System	2016-10-13
PMN K043474 | LFR Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA MG/DL	2016-10-13
PMN K043474 | JJX Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK LINEARITY TEST KIT	2016-10-13
PMN K043474 | JJX Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK Aviva System	2016-10-13
PMN K043474 | JJX Roche Operations, Ltd. [Roche Diagnostics Operations Inc.]	ACCU-CHEK AVIVA MG/DL	2016-10-13

Similar & Related FDA Registered Companies

• Roche Singapore Technical Operations Pte. Ltd
• Roche Singapore Technical Operations Pte. Ltd (RSTO)

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201804109413	Anvers,Belgium -> San Juan, Puerto Rico	MEDICAL INSTRUMENTS CAV-08, CUT ACCUMULATE MA CHINE AND PARTS OF THE MACHINE PACKLIST 6002	8 PCS
201804109413	Anvers,Belgium -> San Juan, Puerto Rico	MEDICAL INSTRUMENTS CAV-08, CUT ACCUMULATE MA CHINE AND PARTS OF THE MACHINE PACKLIST 6002	8 PCS
2018040215861	Anvers,Belgium -> San Juan, Puerto Rico	MEDICAL INSTRUMENTS CAV-09, CUT ACCUMULATE MA CHINE AND PARTS OF THE MACHINE PACKLIST 6002	8 PCS
2018040215861	Anvers,Belgium -> San Juan, Puerto Rico	MEDICAL INSTRUMENTS CAV-09, CUT ACCUMULATE MA CHINE AND PARTS OF THE MACHINE PACKLIST 6002	8 PCS
2018011541849	Stadersand,Federal Republic of Germany -> San Juan, Puerto Rico	HARMLESS DIAGNOSTICS EMPTY VIALS HS CODE 382 20000 GENIII HS CODE 48192000 INSERST HS COD	19 PCS