Roche Diagnostics - FDA 510(k) Cleared Devices
182
Total
180
Cleared
2
Denied
182 devices
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
Nov 01, 2010
ELECSYS CA 125 II CALCHECK 5
Immunology
98d
Cleared
Oct 07, 2010
ELECSYS IGE CALCHECK 5
Immunology
59d
Cleared
Oct 05, 2010
ELECSYS CEA CALCHECK 5
Immunology
96d
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
Jun 22, 2010
ANTI-HAV IGM
Microbiology
181d
Cleared
Jun 22, 2010
TINA-QUANT FERRITIN GEN. 4
Immunology
117d
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
Mar 18, 2010
TINA-QUANT CERULOPLASMIN
Immunology
275d
Cleared
Mar 18, 2010
COAGUCHEK XS PRO SYSTEM
Hematology
132d
Cleared
Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
Microbiology
220d
Cleared
Dec 16, 2009
ELECSYS PROBNP II CALCHECK 5
Chemistry
148d
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