Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
Chemistry
50d
Cleared
Mar 11, 2004
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
Chemistry
34d
Cleared
Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
Immunology
20d
Cleared
Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
Immunology
20d
Cleared
Mar 10, 2004
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
Immunology
20d
Cleared
Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
Chemistry
33d
Cleared
Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
Toxicology
60d
Cleared
Jan 12, 2004
ROCHE ONLINE TDM QUINIDINE
Toxicology
167d
Cleared
Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
Chemistry
167d
Cleared
Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
Chemistry
19d
Cleared
Dec 18, 2003
FACTOR II (PROTHROMBIN) G20210A KIT
Pathology
31d
Cleared
Dec 17, 2003
LIGHTCYCLER INSTRUMENT VERSION 1.2
Chemistry
19d
Not Cleared
Dec 17, 2003
FACTOR V LEIDEN KIT
Pathology
9d
Cleared
Dec 15, 2003
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
Chemistry
62d
Cleared
Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
Chemistry
18d
Cleared
Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
Toxicology
56d
Cleared
Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
Chemistry
12d
Cleared
Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
Chemistry
15d
Cleared
Nov 12, 2003
ELECSYS PROBNP IMMUNOASSAY
Chemistry
77d
Cleared
Oct 17, 2003
ROCHE DIAGNOSTICS OMNI S ANALYZER
Chemistry
81d
Cleared
Oct 16, 2003
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
Chemistry
20d
Cleared
Oct 14, 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
Chemistry
14d
Cleared
Oct 14, 2003
COBAS INTEGRA ALP IFCC GEN.2
Chemistry
13d
Cleared
Oct 10, 2003
ONLINE TDM AMIKA
Toxicology
78d
Cleared
Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
Chemistry
62d
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