Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
264
results for "Roche Diagnostics Corp."
Cleared
Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
Roche Diagnostics Corp.
Chemistry
20d
Cleared
Oct 14, 2003
COBAS INTEGRA ALP IFCC GEN.2
Roche Diagnostics Corp.
Chemistry
13d
Cleared
Oct 14, 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
Roche Diagnostics Corp.
Chemistry
14d
Cleared
Oct 10, 2003
ONLINE TDM AMIKA
Roche Diagnostics Corp.
Toxicology
78d
Cleared
Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
Roche Diagnostics Corp.
Chemistry
62d
Cleared
Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
Roche Diagnostics Corp.
Toxicology
89d
Cleared
Sep 12, 2003
ACCU-CHEK ADVANTAGE SYSTEM
Roche Diagnostics Corp.
Chemistry
24d
Cleared
Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Roche Diagnostics Corp.
Immunology
23d
Cleared
Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
Roche Diagnostics Corp.
Toxicology
51d
Cleared
Aug 21, 2003
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
Roche Diagnostics Corp.
Chemistry
20d
Cleared
Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
Roche Diagnostics Corp.
Toxicology
54d
Cleared
Aug 20, 2003
ELECYS SHBG CALCHECK
Roche Diagnostics Corp.
Chemistry
79d
Cleared
Aug 06, 2003
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
Roche Diagnostics Corp.
Toxicology
51d
Cleared
Aug 05, 2003
TINA-QUANT CRP (LATEX)
Roche Diagnostics Corp.
Chemistry
7d
Cleared
Aug 05, 2003
PRECISET DAT PLUS I CALIBRATORS
Roche Diagnostics Corp.
Chemistry
56d
Cleared
Aug 05, 2003
ELECSYS SHBG IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
63d
Cleared
Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
Roche Diagnostics Corp.
Chemistry
23d
Cleared
Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
Roche Diagnostics Corp.
Chemistry
29d
Cleared
Jul 17, 2003
FERRITIN GENERATION 2
Roche Diagnostics Corp.
Immunology
50d
Cleared
Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
Roche Diagnostics Corp.
Chemistry
28d
Cleared
Jul 09, 2003
COBAS INTEGRA CHOLESTEROL GEN. 2
Roche Diagnostics Corp.
Chemistry
26d
Cleared
Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
Roche Diagnostics Corp.
Chemistry
27d
Cleared
Jun 25, 2003
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY
Roche Diagnostics Corp.
Chemistry
19d
Cleared
May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
Roche Diagnostics Corp.
Hematology
66d