John Roche

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009297077
• FEI Number: 3009297077
• Name: John Roche
• Owner & Operator: Diatron MI Plc
• Contact Address: Tablas u. 39 ; Budapest HU-BU Budapest H-1097 HU
• Official Correspondent:
  • John Roche
  • 36-1-4369800-x
• US Agent:
  • John Roche
  • Diatron US
  • 207 4504228
  • john.roche@diatron.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 12601 NW 115th Avenue ; Medley, FL 33178 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
JJE John Roche [Diatron MI Plc]	Diatron Pictus 500	2015-08-08
JCB John Roche [Diatron MI Plc]	Solution-3: Additive for Wash Solution	2014-04-22
JCB John Roche [Diatron MI Plc]	Solution-2: Rinsing Solution	2014-04-22
JCB John Roche [Diatron MI Plc]	Solution-1: Hypochlorite Cleaning Solution	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroRinse CT	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroHypoclean	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroHypoclean SYS	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroHypoclean CT	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroHypoclean CC	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroHypoclean AX	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroClenz CC	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroCleaner	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroCleaner MN	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroCleaner CT	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroCleaner CD	2014-04-22
JCB John Roche [Diatron MI Plc]	DiatroCleaner AX	2014-04-22
JCB John Roche [Diatron MI Plc]	Diatro Clenz	2014-04-22
JCB John Roche [Diatron MI Plc]	Cleaning Solution Kit	2014-04-22
JCB John Roche [Diatron MI Plc]	Additive for Wash Solution Kit	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroSheath SYS	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroSheath CD 3/3.5	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-Diff	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-Diff MN	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-Diff CT	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-Diff CD	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-Diff AX	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-5P	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-5P CT	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil-5P AX	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil SYS	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil CD 3/3.5	2014-04-22
GIF John Roche [Diatron MI Plc]	DiatroDil CD 3.2	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroReti-Set CT	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroReti CD	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroPack-5 CT	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse-Diff	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse-Diff CT	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse-Diff CD	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse-5P	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse KX SYS	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse Diff MN	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse Diff AX	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse CD 3	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse CD 3.5	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse CD 3.2	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse Baso AX	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse Baso 2 CT	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse Baso 2 AX	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroLyse 3WP SYS	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroGlobin SYS	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroGlobin CD 3.2	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroFix-EO CT	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroFix-EO AX	2014-04-22
GGK John Roche [Diatron MI Plc]	DiatroDiff-5P	2014-04-22
GGK John Roche [Diatron MI Plc]	Diatro AcT Diff Pack CT	2014-04-22
PMN K101741 | JJE John Roche [Diatron MI Plc]	Diatron Pictus 700	2012-12-05
PMN K101741 | JJE John Roche [Diatron MI Plc]	Diatron Pictus 400	2012-12-05
PMN K101741 | JGS John Roche [Diatron MI Plc]	Diatron Pictus 700	2012-12-05
PMN K101741 | JGS John Roche [Diatron MI Plc]	Diatron Pictus 400	2012-12-05
PMN K101741 | CGZ John Roche [Diatron MI Plc]	Diatron Pictus 700	2012-12-05
PMN K101741 | CGZ John Roche [Diatron MI Plc]	Diatron Pictus 400	2012-12-05
PMN K101741 | CGA John Roche [Diatron MI Plc]	Diatron Pictus 700	2012-12-05
PMN K101741 | CGA John Roche [Diatron MI Plc]	Diatron Pictus 400	2012-12-05
PMN K101741 | CEM John Roche [Diatron MI Plc]	Diatron Pictus 700	2012-12-05
PMN K101741 | CEM John Roche [Diatron MI Plc]	Diatron Pictus 400	2012-12-05
PMN K111534 | GKZ John Roche [Diatron MI Plc]	Abacus 3CP Hematology Analyzer	2012-08-07
PMN K112755 | GKZ John Roche [Diatron MI Plc]	Abacus 5 Hematology Analyzer	2012-04-16
PMN K112755 | GKZ John Roche [Diatron MI Plc]	Abacus 5 Autoloader	2012-04-16

Similar & Related FDA Registered Companies

• Diatron US

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020050849714	Yantian,China (Mainland) -> Oakland, California	TOWEL PAPER	1 PCS