Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
145 devices
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 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
Chemistry
156d
Cleared
Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
Chemistry
36d
Cleared
May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
Chemistry
30d
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
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 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
Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
Chemistry
32d
Cleared
Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
Chemistry
27d
Cleared
Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
Chemistry
30d
Cleared
May 02, 2005
ACCU-CHEK INTEGRA SYSTEM
Chemistry
26d
Cleared
Apr 27, 2005
ACCU-CHEK AVIVA SYSTEM
Chemistry
132d
Cleared
Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
Chemistry
21d
Cleared
Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
Chemistry
15d
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