Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
FDA 510(k) cleared devices by Roche Diagnostics Corp. Hematology ✕
16 devices
Cleared
Mar 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
Hematology
162d
Cleared
Jan 31, 2008
HANDHELD BASE UNIT
Hematology
108d
Cleared
Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
Hematology
225d
Cleared
Jan 29, 2007
COAGUCHEK XS SYSTEM
Hematology
123d
Cleared
Jan 29, 2007
COAGUCHEK XS PT CONTROLS
Hematology
34d
Cleared
Sep 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
Hematology
302d
Cleared
May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
Hematology
66d
Cleared
Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
Hematology
22d
Cleared
Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
Hematology
193d
Cleared
Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
Hematology
224d
Cleared
May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
Hematology
46d
Cleared
Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
Hematology
198d
Cleared
Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
Hematology
74d
Cleared
Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
Hematology
258d
Cleared
Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO...
Hematology
143d
Cleared
Nov 02, 1999
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO...
Hematology
99d