Roche Diagnostics Corp. - FDA 510(k) Cleared Devices

Cleared Mar 05, 2010

COAGUCHEK XS PLUS PST SYSTEM

K092940 · GJS

Hematology · 162d

Cleared Jan 31, 2008

HANDHELD BASE UNIT

K072920 · GJS

Hematology · 108d

Cleared Mar 14, 2007

TINA-QUANT D-DIMER TEST SYSTEM

K062203 · GHH

Hematology · 225d

Cleared Jan 29, 2007

COAGUCHEK XS SYSTEM

K062925 · GJS

Hematology · 123d

Cleared Jan 29, 2007

COAGUCHEK XS PT CONTROLS

K063823 · GGN

Hematology · 34d

Cleared Sep 01, 2004

ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY

K033491 · DAP

Hematology · 302d

Cleared May 22, 2003

COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING

K030845 · GJS

Hematology · 66d

Cleared Apr 01, 2003

MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM

K030740 · GHH

Hematology · 22d

Cleared Oct 25, 2002

PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422

K021190 · GJS

Hematology · 193d

Cleared Oct 24, 2002

PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...

K020831 · GJS

Hematology · 224d

Cleared May 29, 2001

TINA-QUANT D-DIMER TEST SYSTEM

K011143 · GHH

Hematology · 46d

Cleared Mar 16, 2001

ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA

K002706 · DAP

Hematology · 198d