Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Apr 03, 1985
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
Toxicology
22d
Cleared
Mar 25, 1985
COBAS FP REAGENTS FOR QUINIDINE
Toxicology
26d
Cleared
Mar 22, 1985
COBAS FP REAGENTS FOR CARBAMAZEPINE
Chemistry
23d
Cleared
Mar 14, 1985
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
Chemistry
45d
Cleared
Feb 27, 1985
ROCHE STANDARDS FOR CHLORIDE & CO2
Chemistry
26d
Cleared
Feb 01, 1985
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
Toxicology
126d
Cleared
Feb 01, 1985
COBAS REAGENTS PHENOBARBITAL & PHENOBAR
Toxicology
126d
Cleared
Feb 01, 1985
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
Toxicology
126d
Cleared
Feb 01, 1985
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
Toxicology
126d
Cleared
Feb 01, 1985
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
Toxicology
126d
Cleared
Jan 18, 1985
ROCHE REAGENTS REAGENT FOR URIC ACID
Chemistry
23d
Cleared
Jan 18, 1985
ROCHE REAGENTS REAGENT FOR CO2
Chemistry
23d
Cleared
Nov 27, 1984
COBAS FLUORESCENCE POLARIZATION MODULE
Toxicology
54d
Cleared
Nov 05, 1984
ROCHE REAGENT FOR AST
Chemistry
90d
Cleared
Oct 30, 1984
COBAS FP TDM CONTROLS
Toxicology
26d
Cleared
Oct 17, 1984
COBAS-FIBRO
Hematology
96d
Cleared
Oct 05, 1984
ROCHE REAGENT FOR ALT
Chemistry
59d
Cleared
Sep 13, 1984
ROCHE STANDARDS FOR URIC ACID
Chemistry
37d
Cleared
Sep 04, 1984
ROCHE STANDARDS FOR CHOLESTEROL
Chemistry
28d
Cleared
Feb 27, 1984
CK-NAC REAGENT
Chemistry
68d
Cleared
May 09, 1983
COBAS STANDARDS FOR GLUCOSE & BUN
Chemistry
40d
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