Roche Diagnostics - FDA 510(k) Cleared Devices
188
Total
185
Cleared
3
Denied
188 devices
Cleared
Feb 28, 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
Chemistry
64d
Cleared
Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
434d
Cleared
Dec 05, 2012
ELECSYS CA 15-3 II CALCHECK 5
Immunology
131d
Cleared
Nov 29, 2012
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190
Chemistry
85d
Cleared
Oct 11, 2012
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
126d
Cleared
Sep 10, 2012
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4...
Immunology
368d
Cleared
Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
Microbiology
56d
Cleared
Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
Microbiology
146d
Cleared
Jul 24, 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3...
Chemistry
236d
Cleared
Jul 17, 2012
ACCU-CHECK COMBO SYSTEM
General Hospital
428d
Cleared
May 14, 2012
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123...
Chemistry
383d
Cleared
May 10, 2012
ELECSYS LH CALCHECK 5
Chemistry
10d
Cleared
May 08, 2012
CALCIUM GEN. 2
Chemistry
161d
Cleared
Jan 06, 2012
GLUCOSE TEST SYSTEM
Chemistry
74d
Cleared
Dec 23, 2011
TINA-QUANT HBA1C GEN.2
Chemistry
324d
Cleared
Dec 23, 2011
ROCHE ACETAMINOPHEN ASSAY
Chemistry
282d
Cleared
Sep 21, 2011
ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
499d
Cleared
Sep 14, 2011
ELECSYS MYOGLOBIN CALCHECK 5
Chemistry
51d
Cleared
Aug 25, 2011
ELECSYS N-MID OSTEOCALCIN CALCHECK 5
Chemistry
34d
Cleared
Jul 21, 2011
ELECSYS T3 CALCHECK 5
Chemistry
48d
Cleared
Jul 08, 2011
ELECSYS PRECICONTROL VARIA 3
Chemistry
37d
Cleared
Jun 09, 2011
ELECSYS SHBG CALCHECK 5
Chemistry
27d
Cleared
May 12, 2011
ROCHE ELECSYS FOLATE RBC
Chemistry
142d
Cleared
May 12, 2011
ELECSYS PROLACTIN II CALCHECK 5
Chemistry
70d
Cleared
May 03, 2011
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL...
Toxicology
76d
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