Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
Chemistry
27d
Cleared
Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
Chemistry
30d
Cleared
May 02, 2005
ACCU-CHEK INTEGRA SYSTEM
Chemistry
26d
Cleared
Apr 27, 2005
ACCU-CHEK AVIVA SYSTEM
Chemistry
132d
Cleared
Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
Immunology
69d
Cleared
Apr 08, 2005
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
General Hospital
108d
Cleared
Mar 11, 2005
ONLINE DAT PROPOXYPHENE PLUS
Toxicology
101d
Cleared
Feb 08, 2005
TINA-QUANT IGG GEN.2
Immunology
21d
Cleared
Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
Toxicology
67d
Cleared
Jan 10, 2005
ONLINE DAT PHENCYCLIDINE PLUS
Toxicology
41d
Cleared
Dec 29, 2004
ONLINE DAT BARBITURATES PLUS
Toxicology
40d
Cleared
Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
Chemistry
21d
Cleared
Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
Chemistry
15d
Cleared
Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
Chemistry
8d
Cleared
Nov 23, 2004
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
Immunology
14d
Cleared
Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH...
Chemistry
46d
Cleared
Sep 30, 2004
ELECSYS FOLATE II CALSET II
Chemistry
16d
Cleared
Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL...
Chemistry
12d
Cleared
Sep 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
Hematology
302d
Cleared
Jul 27, 2004
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND...
Chemistry
21d
Cleared
May 27, 2004
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL...
Chemistry
17d
Cleared
May 17, 2004
ELECSYS TROPONIN T STAT TEST
Chemistry
56d
Cleared
May 14, 2004
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
Chemistry
109d
Cleared
Apr 22, 2004
ACCU-CHEK GO SYSTEM
Chemistry
24d
Cleared
Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
Chemistry
58d
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