Roche Diagnostics - FDA 510(k) Cleared Devices
177
Total
175
Cleared
2
Denied
115 devices
Cleared
Jul 17, 2013
COBAS C BILIRUBIN TOTAL GEN.3
Chemistry
49d
Not Cleared
May 23, 2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
Chemistry
59d
Cleared
May 21, 2013
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
Chemistry
168d
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
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
Jul 24, 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3...
Chemistry
236d
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
Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
Chemistry
402d
Cleared
Feb 11, 2011
ROCHE ORAL FLUID COCAINE
Chemistry
291d
Cleared
Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
Chemistry
397d
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