Roche Diagnostics - FDA 510(k) Cleared Devices
188
Total
185
Cleared
3
Denied
188 devices
Cleared
May 11, 2007
COAGUCHEK XS PLUS SYSTEM
Hematology
29d
Cleared
Feb 16, 2007
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
Toxicology
87d
Cleared
Aug 31, 2006
ELECSYS IGE II IMMUNOASSAY
Immunology
50d
Cleared
Aug 11, 2006
COAGUCHEK XS SYSTEM
Hematology
123d
Cleared
Mar 13, 2006
COBAS 6000 SERIES SYSTEM
Immunology
28d
Cleared
Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
Chemistry
28d
Cleared
Oct 28, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
Chemistry
4d
Cleared
Oct 03, 2005
ISE COMPENSATOR
Chemistry
53d
Cleared
Aug 26, 2005
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
Chemistry
23d
Cleared
Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL,...
Chemistry
89d
Cleared
Jul 11, 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
Chemistry
12d
Cleared
Apr 22, 2005
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
Chemistry
63d
Cleared
Jan 31, 2005
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
Chemistry
25d
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