Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
479
results for "Roche Diagnostics"
Cleared
Oct 28, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
Roche Diagnostics
Chemistry
4d
Cleared
Oct 17, 2005
ELECSYS PRECICONTROL BONE
Roche Diagnostics Corp.
Chemistry
129d
Cleared
Oct 03, 2005
ISE COMPENSATOR
Roche Diagnostics
Chemistry
53d
Cleared
Sep 30, 2005
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
Roche Diagnostics Corp.
Chemistry
22d
Cleared
Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Roche Diagnostics Corp.
General Hospital
173d
Cleared
Sep 08, 2005
ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN...
Roche Diagnostics Corp.
Chemistry
113d
Cleared
Sep 02, 2005
MODIFICATION TO ACCU-CHEK GO SYSTEM
Roche Diagnostics Corp.
Chemistry
79d
Cleared
Aug 26, 2005
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
Roche Diagnostics
Chemistry
23d
Cleared
Aug 23, 2005
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL,...
Roche Diagnostics
Chemistry
89d
Cleared
Aug 22, 2005
IRON STANDARD
Roche Diagnostics Corp.
Chemistry
28d
Cleared
Aug 04, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
Roche Diagnostics Corp.
Immunology
23d
Cleared
Jul 25, 2005
ELECSYS PRECICONTROL UNIVERSAL
Roche Diagnostics Corp.
Chemistry
32d
Cleared
Jul 11, 2005
ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
Roche Diagnostics
Chemistry
12d
Cleared
Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
Roche Diagnostics Corp.
Immunology
58d
Cleared
Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
Roche Diagnostics Corp.
Immunology
161d
Cleared
Jul 05, 2005
ELECSYS PRECICONTROL ANEMIA
Roche Diagnostics Corp.
Chemistry
27d
Cleared
Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
Roche Diagnostics Corp.
Chemistry
30d
Cleared
May 02, 2005
ACCU-CHEK INTEGRA SYSTEM
Roche Diagnostics Corp.
Chemistry
26d
Cleared
Apr 27, 2005
ACCU-CHEK AVIVA SYSTEM
Roche Diagnostics Corp.
Chemistry
132d
Cleared
Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
Roche Diagnostics Corp.
Immunology
69d
Cleared
Apr 22, 2005
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
Roche Diagnostics
Chemistry
63d
Cleared
Apr 08, 2005
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
Roche Diagnostics Corp.
General Hospital
108d
Cleared
Mar 11, 2005
ONLINE DAT PROPOXYPHENE PLUS
Roche Diagnostics Corp.
Toxicology
101d
Cleared
Feb 08, 2005
TINA-QUANT IGG GEN.2
Roche Diagnostics Corp.
Immunology
21d