Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Jul 17, 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
Chemistry
36d
Cleared
Jun 26, 1990
COBAS READY PROFILE 2 REAGENT STRIP
Chemistry
239d
Cleared
Jun 26, 1990
COBAS READY CALIBRATOR KIT
Chemistry
187d
Cleared
Jun 12, 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
Chemistry
118d
Cleared
May 30, 1990
ROTAG CONTROLS
Chemistry
105d
Cleared
May 23, 1990
ROCHE REAGENT FOR MAGNESIUM
Chemistry
35d
Cleared
May 02, 1990
COBAS-FP REAGENTS FOR VANCOMYCIN
Chemistry
14d
Cleared
Mar 30, 1990
ROCHE REAGENT FOR LDH
Chemistry
80d
Cleared
Mar 09, 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
Chemistry
77d
Cleared
Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
Chemistry
59d
Cleared
Mar 09, 1990
ABUSCREEN FP FOR METHAMPHETAMINE
Toxicology
57d
Cleared
Feb 27, 1990
COBAS READY TOTAL BILIRUBIN REAGENT
Chemistry
120d
Cleared
Feb 27, 1990
COBAS READY ALBUMIN REAGENT
Chemistry
120d
Cleared
Feb 27, 1990
COBAS READY BUN REAGENT
Chemistry
120d
Cleared
Feb 16, 1990
COBAS READY URIC ACID REAGENT
Chemistry
109d
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
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