Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
145 devices
Cleared
Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
Chemistry
62d
Cleared
Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
Chemistry
24d
Cleared
Aug 21, 2003
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
Chemistry
20d
Cleared
Aug 20, 2003
ELECYS SHBG CALCHECK
Chemistry
79d
Cleared
Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
Chemistry
63d
Cleared
Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
Chemistry
56d
Cleared
Aug 05, 2003
TINA-QUANT CRP (LATEX)
Chemistry
7d
Cleared
Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
Chemistry
23d
Cleared
Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
Chemistry
29d
Cleared
Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
Chemistry
28d
Cleared
Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
Chemistry
26d
Cleared
Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
Chemistry
27d
Cleared
Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
Chemistry
19d
Cleared
May 12, 2003
ELECSYS LH CALSET II
Chemistry
18d
Cleared
Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
Chemistry
7d
Cleared
Nov 29, 2002
ELECSYS PROBNP CALCHECK
Chemistry
256d
Cleared
Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
Chemistry
112d
Cleared
Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
Chemistry
145d
Cleared
Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
Chemistry
20d
Cleared
Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
Chemistry
20d
Cleared
Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Chemistry
29d
Cleared
Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
Chemistry
33d
Cleared
Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Chemistry
28d
Cleared
Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
Chemistry
94d
Cleared
Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
Chemistry
135d
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