Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
Chemistry
36d
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 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
Chemistry
30d
Cleared
May 11, 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
Toxicology
65d
Cleared
May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
Chemistry
57d
Cleared
Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
Chemistry
28d
Cleared
Apr 10, 2006
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
Chemistry
20d
Cleared
Mar 15, 2006
TDM CONTROL SET
Chemistry
22d
Cleared
Feb 16, 2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
Chemistry
34d
Cleared
Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA...
Chemistry
48d
Cleared
Feb 07, 2006
ROCHE ELECSYS ANTI-TG
Immunology
61d
Cleared
Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
Chemistry
30d
Cleared
Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
Chemistry
192d
Cleared
Oct 17, 2005
ELECSYS PRECICONTROL BONE
Chemistry
129d
Cleared
Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
Chemistry
22d
Cleared
Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
General Hospital
173d
Cleared
Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN...
Chemistry
113d
Cleared
Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
Chemistry
79d
Cleared
Aug 22, 2005
IRON STANDARD
Chemistry
28d
Cleared
Aug 04, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
Immunology
23d
Cleared
Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
Chemistry
32d
Cleared
Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
Immunology
161d
Cleared
Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
Immunology
58d
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