Roche Diagnostics Corp. is one of 5253 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
Roche Diagnostics Corp. has 263 FDA 510(k) cleared medical devices. Based in Indianapolis, US.
Historical record: 263 cleared submissions from 1999 to 2013. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Roche Diagnostics Corp. Filter by specialty or product code using the sidebar.
Roche Diagnostics Corp. — FDA 510(k) Products and Clearance History
264 devices
Cleared
Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
Chemistry
56d
Cleared
Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
Immunology
141d
Cleared
Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
Chemistry
167d
Cleared
Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
General Hospital
120d
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 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
Hematology
162d
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
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