Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
FDA 510(k) cleared devices by Roche Diagnostics Corp. Toxicology ✕
52 devices
Cleared
Mar 21, 2008
COBAS LITHIUM
Toxicology
465d
Cleared
Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
Toxicology
89d
Cleared
Aug 23, 2006
ONLINE TDM PROCAINAMIDE
Toxicology
154d
Cleared
Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
Toxicology
149d
Cleared
Aug 08, 2006
ONLINE VALPROIC ACID
Toxicology
146d
Cleared
Jul 03, 2006
CHOLINESTERASE GEN.2 TEST SYSTEM
Toxicology
75d
Cleared
Jun 09, 2006
ONLINE TDM TOBRAMYCIN
Toxicology
72d
Cleared
May 30, 2006
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS...
Toxicology
81d
Cleared
May 11, 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
Toxicology
65d
Cleared
Mar 11, 2005
ONLINE DAT PROPOXYPHENE PLUS
Toxicology
101d
Cleared
Feb 07, 2005
ONLINE DAT BENZODIAZEPINES PLUS
Toxicology
67d
Cleared
Jan 10, 2005
ONLINE DAT PHENCYCLIDINE PLUS
Toxicology
41d
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