DIS · Class II · 21 CFR 862.3150

FDA Product Code DIS: Enzyme Immunoassay, Barbiturate

Leading manufacturers include Syva Co., Abbott Laboratories and Princeton BioMeditech Corp..

100
Total
100
Cleared
97d
Avg days
1979
Since
100 devices
49–72 of 100
Cleared Feb 12, 1998
QUIKSTRIP ONE STEP BARBITURATE TEST
K974712
Syntron Bioresearch, Inc.
Toxicology · 57d
Cleared Oct 02, 1997
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST
K973047
Drial Consultants, Inc.
Toxicology · 48d
Cleared Oct 30, 1996
VERDICT BARBITURATES
K963529
Editek, Inc.
Toxicology · 56d
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 Jul 18, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K941489
Schiapparelli Biosystems, Inc.
Chemistry · 112d
Cleared Mar 22, 1994
CEDIA DAU BARBITURATE ASSAY
K936030
Microgenics Corp.
Toxicology · 95d
Cleared Dec 07, 1993
STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
K934376
Solarcare, Inc.
Toxicology · 89d
Cleared Oct 29, 1993
MICROLINE SCREEN FOR BARBITURATES
K933480
Drug Screening Systems, Inc.
Toxicology · 106d
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 Aug 05, 1992
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
K920525
Biotrack, Inc.
Toxicology · 183d
Cleared Apr 24, 1992
IL TEST BARBITURATE, 35289
K920417
Instrumentation Laboratory CO
Toxicology · 84d