Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Oct 09, 1997
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK...
Toxicology
52d
Cleared
Oct 01, 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000...
Chemistry
57d
Cleared
Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
Chemistry
57d
Cleared
Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
Chemistry
16d
Cleared
Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
Chemistry
12d
Cleared
Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
Chemistry
24d
Cleared
Feb 04, 1997
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
Toxicology
75d
Cleared
Jan 13, 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
Chemistry
68d
Cleared
Dec 13, 1996
ONTRAK TESTCUP 5 (MODIFICATION)
Toxicology
42d
Cleared
Nov 25, 1996
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
Toxicology
20d
Cleared
Oct 31, 1996
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
Chemistry
71d
Cleared
Oct 24, 1996
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
Chemistry
43d
Cleared
Oct 07, 1996
ONTRAK TESTCUP AMPHETAMINES
Toxicology
108d
Cleared
Sep 27, 1996
ROCHE UNIMATE FRUCTOSAMINE REAGENT
Chemistry
149d
Cleared
Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
Chemistry
81d
Cleared
Aug 16, 1996
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
Toxicology
64d
Cleared
Jul 23, 1996
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
Immunology
74d
Cleared
Jul 11, 1996
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
Toxicology
69d
Cleared
Jun 26, 1996
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
Toxicology
22d
Cleared
Jun 21, 1996
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
Toxicology
67d
Cleared
Jun 13, 1996
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
Toxicology
48d
Cleared
Feb 13, 1996
ROCHE REAGENT FOR GLUCOSE
Chemistry
181d
Cleared
Feb 09, 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
Hematology
266d
Cleared
Jan 25, 1996
ROCHE COBAS INTEGRA REAGENT CASSETTES
Chemistry
86d
Cleared
Dec 21, 1995
ROCHE CONTROL SERUM N
Immunology
72d
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