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

FDA 510(k) Cleared Enzyme Immunoassay, Barbiturate Devices (Product Code DIS)

100 devices
1–24 of 100
Cleared Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K161714
Immunalysis Corporation
Toxicology · 115d
Cleared Apr 24, 2015
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
K150791
Healgen Scientific, LLC
Toxicology · 30d
Cleared Dec 29, 2004
ONLINE DAT BARBITURATES PLUS
K043211
Roche Diagnostics Corp.
Toxicology · 40d
Cleared Mar 20, 2002
BARBITURATES
K012996
Abbott Laboratories
Toxicology · 195d
Cleared Apr 03, 2000
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459
Dade Behring, Inc.
Toxicology · 52d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440
Roche Diagnostics Corp.
Toxicology · 57d
Cleared May 03, 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698
Roche Diagnostic Systems, Inc.
Toxicology · 194d
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 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 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 Apr 24, 1992
IL TEST BARBITURATE, 35289
K920417
Instrumentation Laboratory CO
Toxicology · 84d
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
Cleared Aug 08, 1988
EMIT HVA BARBITURATE ASSAY
K882611
Syva Co.
Toxicology · 45d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX BARBITURATES
K880012
Abbott Laboratories
Toxicology · 57d
Cleared Jan 05, 1988
REVISED LABELING FOR SYVA BARBITURATE ASSAYS
K874702
Syva Co.
Toxicology · 50d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BARBITURATES
K874483
Abbott Laboratories
Toxicology · 24d

About Product Code DIS - Regulatory Context