Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
FDA 510(k) cleared devices by Roche Diagnostics Corp. Chemistry ✕
145 devices
Cleared
Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
Chemistry
56d
Cleared
Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
Chemistry
167d
Cleared
Jul 28, 2010
AMPHETAMINES II ASSAY
Chemistry
243d
Cleared
Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
Chemistry
53d
Cleared
Apr 23, 2010
ELECSYS TESTOSTERONE II IMMUNOASSAY
Chemistry
171d
Cleared
Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
Chemistry
184d
Cleared
Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
Chemistry
93d
Cleared
Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS...
Chemistry
160d
Cleared
Feb 03, 2010
AMPHETAMINES II
Chemistry
412d
Cleared
Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
Chemistry
114d
Cleared
Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE...
Chemistry
308d
Cleared
Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C...
Chemistry
88d
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