DIS · Class II · 21 CFR 862.3150

FDA Product Code DIS: Enzyme Immunoassay, Barbiturate

Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..

100
Total
100
Cleared
97d
Avg days
1979
Since
100 devices
25–48 of 100
Cleared Aug 18, 1998
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN
K982551
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Aug 15, 1996
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669
Princeton BioMeditech Corp.
Toxicology · 37d
Cleared Jun 28, 1996
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD
K961010
Princeton BioMeditech Corp.
Toxicology · 107d
Cleared May 06, 1996
BARBITURATE SERUM TOX EIA ASSAY
K960664
Diagnostic Reagents, Inc.
Toxicology · 80d
Cleared Mar 11, 1996
BARBITURATE EIA ESSAY (MODIFICATION)
K955928
Diagnostic Reagents, Inc.
Toxicology · 84d
Cleared Dec 11, 1995
ACS PHENOBARBITAL
K953021
Ciba Corning Diagnostics Corp.
Toxicology · 165d
Cleared May 18, 1995
AXSYM BARBITURATES II U
K951253
Abbott Laboratories
Toxicology · 58d
Cleared Apr 13, 1995
URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950137
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 90d
Cleared Feb 22, 1995
EMIT IIC BARBITURATE ASSAY
K935116
Syva Co.
Toxicology · 483d
Cleared Dec 29, 1994
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST
K944075
Beckman Instruments, Inc.
Toxicology · 177d
Cleared Dec 28, 1994
CEDIA DAU BARBITURATE ASSAY
K945344
Microgenics Corp.
Toxicology · 57d
Cleared Aug 30, 1994
CEDIA DAU BARBITURATE ASSAY
K942436
Microgenics Corp.
Toxicology · 124d
Cleared Jul 28, 1994
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404
Microgenics Corp.
Toxicology · 129d
Cleared Mar 22, 1994
CEDIA DAU BARBITURATE ASSAY
K936030
Microgenics Corp.
Toxicology · 95d
Cleared Jun 15, 1993
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535
Syva Co.
Toxicology · 78d
Cleared Jan 12, 1993
EMIT(R) II BARBITURATE ASSAY
K926068
Syva Co.
Toxicology · 42d
Cleared Dec 30, 1992
BARBITURATE EIA TEST
K925491
Diagnostic Reagents, Inc.
Toxicology · 58d
Cleared Apr 24, 1992
IL TEST BARBITURATE, 35289
K920417
Instrumentation Laboratory CO
Toxicology · 84d
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM
K903825
Technicon Instruments Corp.
Toxicology · 38d
Cleared Jul 19, 1990
EMIT(R) II BARBITURATE ASSAY
K902580
Syva Co.
Toxicology · 38d
Cleared Dec 19, 1989
TDX(R) BARBITURATES II ASSAY
K896550
Abbott Laboratories
Toxicology · 32d
Cleared Aug 25, 1989
ADX TM BARBITURATES
K890690
Abbott Laboratories
Toxicology · 192d
Cleared May 16, 1989
TDX BARBITURATES SERUM
K892650
Abbott Laboratories
Chemistry · 34d
Cleared Mar 09, 1989
ABUSCREEN FP FOR BARBITURATES
K890884
Roche Diagnostic Systems, Inc.
Toxicology · 16d