Lsi Medience Corp

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010736318
• FEI Number: 3010736318
• Name: LSI MEDIENCE CORPORATION
• Owner & Operator: LSI MEDIENCE CORPORATION
• Contact Address: 13-4, Uchikanda 1-chome ; Chiyoda-ku JP-13 Tokyo 101-8517 JP
• US Agent:
  • Timothy Huang
  • PHC Corporation of North America
  • 757 5280196
  • tim.huang@us.phchd.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 13-4, Uchikanda 1-chome ; Chiyoda-ku Tokyo, 101-8517 JP
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3004932970
• FEI Number: 3004932970
• Name: Timothy Huang
• Owner & Operator: LSI MEDIENCE CORPORATION
• Contact Address: 13-4, Uchikanda 1-chome ; Chiyoda-ku JP-13 Tokyo 101-8517 JP
• US Agent:
  • Timothy Huang
  • PHC Corporation of North America
  • 757 5280196
  • tim.huang@us.phchd.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Two Riverfront Plaza, 2nd Floor, ; Newark, NJ 07102 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 04987595300646 LSI MEDIENCE CORPORATION	PATHFAST 300646	2023-06-20
GUDID 04987595301742 LSI MEDIENCE CORPORATION	PATHFAST hsCRP	2018-07-06
GUDID 04987595301636 LSI MEDIENCE CORPORATION	PATHFAST NTproBNP	2018-07-06
GUDID 04987595301339 LSI MEDIENCE CORPORATION	PATHFAST CK-MB-II	2018-07-06
GUDID 04987595301230 LSI MEDIENCE CORPORATION	PATHFAST Myo-II	2018-07-06
GUDID 04987595301131 LSI MEDIENCE CORPORATION	PATHFAST cTnI-II	2018-07-06
GUDID 04987595301537 LSI MEDIENCE CORPORATION	PATHFAST D-Dimer	2018-03-29
PPM Timothy Huang [LSI MEDIENCE CORPORATION]	Tris-buffer for stabilizing	2014-03-24
PPM LSI MEDIENCE CORPORATION	Tris-buffer for stabilizing	2014-03-24
MVU Timothy Huang [LSI MEDIENCE CORPORATION]	Latex sensitized anti-adiponectin antibody	2013-03-22
MVU LSI MEDIENCE CORPORATION	Latex sensitized anti-adiponectin antibody	2013-03-22
PMN K100130 | MMI Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST cTnI-II test; PATHFAST cTnI Calibrators	2011-06-07
PMN K100130 | MMI Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST Sample Diluent 2	2011-06-07
PMN K100130 | MMI LSI MEDIENCE CORPORATION	PATHFAST cTnI-II test; PATHFAST cTnI Calibrators	2011-06-07
PMN K100130 | MMI LSI MEDIENCE CORPORATION	PATHFAST Sample Diluent 2	2011-06-07
PMN K100130 | JIT Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST cTnI-II test; PATHFAST cTnI Calibrators	2011-06-07
PMN K100130 | JIT Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST Sample Diluent 2	2011-06-07
PMN K100130 | JIT LSI MEDIENCE CORPORATION	PATHFAST cTnI-II test; PATHFAST cTnI Calibrators	2011-06-07
PMN K100130 | JIT LSI MEDIENCE CORPORATION	PATHFAST Sample Diluent 2	2011-06-07
PMN K081360 | JIT Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST Sample Diluent 1	2009-09-08
PMN K081360 | JIT Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST CK-MB-II, and Myo-II tests	2009-09-08
PMN K081360 | JIT LSI MEDIENCE CORPORATION	PATHFAST Sample Diluent 1	2009-09-08
PMN K081360 | JIT LSI MEDIENCE CORPORATION	PATHFAST CK-MB-II, and Myo-II tests	2009-09-08
PMN K081360 | JHX Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST Sample Diluent 1	2009-09-08
PMN K081360 | JHX Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST CK-MB-II, and Myo-II tests	2009-09-08
PMN K081360 | JHX LSI MEDIENCE CORPORATION	PATHFAST Sample Diluent 1	2009-09-08
PMN K081360 | JHX LSI MEDIENCE CORPORATION	PATHFAST CK-MB-II, and Myo-II tests	2009-09-08
PMN K081360 | DDR Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST Sample Diluent 1	2009-09-08
PMN K081360 | DDR Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST CK-MB-II, and Myo-II tests	2009-09-08
PMN K081360 | DDR LSI MEDIENCE CORPORATION	PATHFAST Sample Diluent 1	2009-09-08
PMN K081360 | DDR LSI MEDIENCE CORPORATION	PATHFAST CK-MB-II, and Myo-II tests	2009-09-08
PMN K083412 | JIT Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST hsCRP	2009-07-27
PMN K083412 | JIT LSI MEDIENCE CORPORATION	PATHFAST hsCRP	2009-07-27
PMN K083412 | DCN Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST hsCRP	2009-07-27
PMN K083412 | DCN LSI MEDIENCE CORPORATION	PATHFAST hsCRP	2009-07-27
PMN K072288 | GHH Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST D-Dimer	2009-07-27
PMN K072288 | GHH LSI MEDIENCE CORPORATION	PATHFAST D-Dimer	2009-07-27
PMN K072189 | NBC Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST NTproBNP	2008-02-01
PMN K072189 | NBC LSI MEDIENCE CORPORATION	PATHFAST NTproBNP	2008-02-01
JJE Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST	2008-02-01
JJE Timothy Huang [LSI MEDIENCE CORPORATION]	PATHFAST TIP	2008-02-01
JJE LSI MEDIENCE CORPORATION	PATHFAST	2008-02-01
JJE LSI MEDIENCE CORPORATION	PATHFAST TIP	2008-02-01