Roche Diagnostics - FDA 510(k) Cleared Devices
182
Total
180
Cleared
2
Denied
182 devices
Cleared
Oct 17, 2014
ELECSYS FOLATE III
Chemistry
140d
Cleared
Sep 05, 2014
ELECSYS ESTRADIOL III CALCHECK 5
Chemistry
32d
Cleared
Aug 29, 2014
ACCU-CHEK Performa Blood Glucose Monitoring System
Chemistry
263d
Cleared
Aug 12, 2014
Elecsys Estradiol III CalSet
Chemistry
18d
Cleared
Jul 17, 2014
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR,...
Chemistry
76d
Cleared
Jun 06, 2014
CA 125 II CALSET II
Immunology
142d
Cleared
May 22, 2014
ISE INDIRECT NA, K, C1 FOR GEN 2
Chemistry
97d
Cleared
May 08, 2014
ELECSYS CK-MB STAT IMMUNOASSAY
Chemistry
79d
Cleared
Mar 27, 2014
ELECSYS PRECICONTROL TS
Chemistry
23d
Cleared
Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
Microbiology
270d
Cleared
Jan 27, 2014
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
Chemistry
271d
Cleared
Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
Chemistry
138d
Cleared
Dec 04, 2013
ELECSYS CALCITONIN
Chemistry
86d
Cleared
Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM...
Chemistry
25d
Cleared
Nov 22, 2013
ELECSYS CK-MB CALCHECK 5
Chemistry
28d
Cleared
Oct 18, 2013
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
Chemistry
64d
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
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
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