Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Mar 06, 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
Immunology
106d
Cleared
Feb 27, 2008
ELECSYS PROBNP II CALCHECK
Chemistry
36d
Cleared
Jan 31, 2008
HANDHELD BASE UNIT
Hematology
108d
Cleared
Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
Chemistry
31d
Cleared
Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
Toxicology
89d
Cleared
Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
Chemistry
121d
Cleared
May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
Chemistry
85d
Cleared
May 09, 2007
ACCU-CHEK SMART PIX
Chemistry
266d
Cleared
Mar 20, 2007
ELECSYS PTH TEST SYSTEM
Chemistry
39d
Cleared
Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
Chemistry
56d
Cleared
Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
Hematology
225d
Cleared
Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
Immunology
191d
Cleared
Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
Chemistry
169d
Cleared
Jan 29, 2007
COAGUCHEK XS SYSTEM
Hematology
123d
Cleared
Jan 29, 2007
COAGUCHEK XS PT CONTROLS
Hematology
34d
Cleared
Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS...
Chemistry
28d
Cleared
Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
Chemistry
14d
Cleared
Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
Chemistry
35d
Cleared
Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
Chemistry
40d
Cleared
Aug 23, 2006
ONLINE TDM PROCAINAMIDE
Toxicology
154d
Cleared
Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
Toxicology
149d
Cleared
Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
Chemistry
156d
Cleared
Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Microbiology
258d
Cleared
Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Microbiology
258d
Cleared
Aug 08, 2006
ONLINE VALPROIC ACID
Toxicology
146d
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