Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
145 devices
Cleared
Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
Chemistry
8d
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
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
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
Feb 25, 2004
ELECSYS C-PEPTIDE CALCHECK
Chemistry
33d
Cleared
Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
Chemistry
167d
Cleared
Jan 07, 2004
ELECSYS PRECICONTROL MULTIANALYTE
Chemistry
19d
Cleared
Dec 17, 2003
LIGHTCYCLER INSTRUMENT VERSION 1.2
Chemistry
19d
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
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
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