Roche Diagnostics - FDA 510(k) Cleared Devices
182
Total
180
Cleared
2
Denied
182 devices
Cleared
Dec 04, 2009
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
Chemistry
101d
Cleared
Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
Chemistry
118d
Cleared
Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
Chemistry
91d
Cleared
Oct 30, 2009
ELECSYS RUBELLA IGGA CALCHECK 5
Microbiology
67d
Cleared
Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
Chemistry
345d
Cleared
Aug 19, 2009
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
Chemistry
338d
Cleared
Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
Chemistry
122d
Cleared
Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT...
Chemistry
76d
Cleared
May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
Microbiology
88d
Cleared
Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
Microbiology
64d
Cleared
Jan 16, 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
Chemistry
263d
Cleared
Oct 28, 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
General Hospital
50d
Cleared
Sep 11, 2008
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
Immunology
121d
Cleared
Aug 22, 2008
ELECSYS ANTI-TSHR CALCHECK
Chemistry
169d
Cleared
Jul 15, 2008
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
57d
Cleared
Feb 05, 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
Chemistry
166d
Cleared
Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
Chemistry
197d
Cleared
Sep 14, 2007
TOTAL PROTEIN URINE/CSF GEN.3
Chemistry
134d
Cleared
Jul 30, 2007
COBAS C 111 ANALYZER
Chemistry
90d
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
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