Roche Diagnostics - FDA 510(k) Cleared Devices
177
Total
175
Cleared
2
Denied
115 devices
Cleared
Jan 20, 2011
ELECYSYS SHBG
Chemistry
114d
Cleared
Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
Chemistry
49d
Cleared
Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
Chemistry
52d
Cleared
Dec 06, 2010
PRECICONTROL HBA1C NORM
Chemistry
47d
Cleared
Nov 18, 2010
ELECSYS PTH CALCHECK 5
Chemistry
22d
Cleared
Sep 10, 2010
TINA-QUANT ALBUMIN GEN 2
Chemistry
134d
Cleared
Sep 10, 2010
ELECSYS FERRITIN CALCHECK 5
Chemistry
32d
Cleared
Sep 08, 2010
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS...
Chemistry
105d
Cleared
Sep 01, 2010
PRECICONTROL CLINCHEM MULTI 1 AND 2
Chemistry
44d
Cleared
Aug 31, 2010
ELECSYS DIGOXIN CALCHECK 5
Chemistry
41d
Cleared
Aug 27, 2010
ELECSYS PRECICONTROL MULTIMARKER
Chemistry
28d
Cleared
Apr 27, 2010
ELECSYS FOLATE III CALCHECK 5
Chemistry
118d
Cleared
Apr 26, 2010
ELECSYS C-PEPTIDE CALCHECK 5
Chemistry
35d
Cleared
Apr 15, 2010
ELECSYS TSH CALCHECK 5
Chemistry
121d
Cleared
Apr 02, 2010
COBAS U411 TEST SYSTEM
Chemistry
136d
Cleared
Apr 01, 2010
ELECSYS TROPONIN I CALCHECK 5
Chemistry
30d
Cleared
Mar 29, 2010
ELECSYS CK-MB CALCHECK 5
Chemistry
130d
Cleared
Dec 16, 2009
ELECSYS PROBNP II CALCHECK 5
Chemistry
148d
Cleared
Dec 04, 2009
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
Chemistry
101d
Cleared
Nov 16, 2009
ELECSYS HCG+B CALCHECK 5
Chemistry
118d
Cleared
Nov 03, 2009
ELECSYS PRECICONTROL THYROAB
Chemistry
91d
Cleared
Oct 16, 2009
ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
Chemistry
345d
Cleared
Aug 19, 2009
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
Chemistry
338d
Cleared
Jul 02, 2009
ELECSYS PRECICONTROL UNIVERSAL
Chemistry
122d
Cleared
Jun 18, 2009
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT...
Chemistry
76d
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