Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
118 devices
Cleared
Aug 12, 1991
ROCHE REAGENT FOR ETHANOL
Chemistry
28d
Cleared
Jul 19, 1991
ROCHE REAGENT FOR C02
Chemistry
85d
Cleared
Apr 24, 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
Chemistry
71d
Cleared
Apr 24, 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
Chemistry
71d
Cleared
Oct 12, 1990
ROCHE COBAS READY GGT REAGENT
Chemistry
80d
Cleared
Oct 12, 1990
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
Chemistry
38d
Cleared
Sep 27, 1990
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
Chemistry
86d
Cleared
Sep 07, 1990
ROCHE COBAS READY CREATININE REAGENT
Chemistry
88d
Cleared
Sep 07, 1990
ROCHE COBAS READY AMYLASE REAGENT
Chemistry
45d
Cleared
Aug 17, 1990
COBAS READY CALCIUM REAGENT
Chemistry
291d
Cleared
Aug 09, 1990
ROCHE ISOMUNE- CK
Chemistry
30d
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
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
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