Roche Diagnostics Corp. is one of 5511 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
Recent clearances: SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM, ELECSYS CA 19-9 CALCHECK 5, COBAS 8000 MODULAR SERIES ANALYZER
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.
510(k) submissions have been managed by Tuv Product Service, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Roche Diagnostics Corp.
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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