Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
118 devices
Cleared
Feb 16, 1990
COBAS READY CARDIO PROFILE REAGENT STRIP
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY PROFILE 1 REAGENT STRIP
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY TOTAL PROTEIN REAGENT
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY LIVER PROFILE REAGENT STRIP
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY STAT PROFILE REAGENT STRIP
Chemistry
108d
Cleared
Feb 16, 1990
COBAS READY ALT REAGENT
Chemistry
108d
Cleared
Feb 16, 1990
COBAS READY AST REAGENT
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY CHOLESTEROL REAGENT
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY CK REAGENT
Chemistry
109d
Cleared
Feb 16, 1990
COBAS READY LDH REAGENT
Chemistry
109d
Cleared
Dec 19, 1989
COBAS READY
Chemistry
67d
Cleared
Dec 01, 1989
ISOSCREEN-CK CONFIRMATORY KIT
Chemistry
58d
Cleared
Oct 16, 1989
COBAS READY GLUCOSE REAGENT
Chemistry
34d
Cleared
Sep 05, 1989
ROCHE REAGENT FOR URIC ACID
Chemistry
88d
Cleared
Aug 31, 1989
ROCHO ISOMUNE - LD
Chemistry
84d
Cleared
Aug 11, 1989
ROCHE REAGENT FOR TRIGLYCERIDES
Chemistry
70d
Cleared
Aug 03, 1989
COBAS FARA II CENTRIFUGAL ANALYZER
Chemistry
70d
Cleared
Jul 20, 1989
COBAS FARA CENTRIFUGAL ANALYZER
Chemistry
66d
Cleared
May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
Chemistry
68d
Cleared
Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
Chemistry
57d
Cleared
Mar 22, 1989
COBAS MFC
Chemistry
85d
Cleared
Dec 09, 1988
ROCHE REAGENT FOR CHLORIDE
Chemistry
78d
Cleared
Nov 29, 1988
ROCHE REAGENT FOR INORGANIC PHOSPHORUS
Chemistry
70d
Cleared
Oct 25, 1988
ROCHE REAGENT FOR CALCIUM
Chemistry
74d
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