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

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 Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
K143535
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 29d
Cleared May 25, 2011
RANDOX BARITURATES ASSAY
K092268
Randox Laboratories, Ltd.
Toxicology · 666d
Cleared Jan 05, 2007
VITROS CHEMISTRY PRODUCTS BARB REAGENT
K062165
Ortho-Clinical Diagnostics
Chemistry · 161d
Cleared Nov 17, 2005
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
K050024
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 316d
Cleared May 06, 2005
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Dec 29, 2004
ONLINE DAT BARBITURATES PLUS
K043211
Roche Diagnostics Corp.
Toxicology · 40d
Cleared Nov 05, 2004
RANDOX BARBITURATE ASSAY
K041143
Randox Laboratories, Ltd.
Toxicology · 189d
Cleared May 19, 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885
Lin-Zhi International, Inc.
Toxicology · 156d
Cleared Nov 03, 2003
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)
K032764
Lin-Zhi International, Inc.
Toxicology · 59d
Cleared Feb 05, 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
K023946
ACON Laboratories, Inc.
Toxicology · 70d
Cleared Mar 20, 2002
BARBITURATES
K012996
Abbott Laboratories
Toxicology · 195d
Cleared Nov 09, 2001
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824
ACON Laboratories, Inc.
Toxicology · 78d
Cleared May 29, 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125
Alfa Scientific Designs, Inc.
Toxicology · 183d
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 Apr 15, 1999
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
K991018
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP
K991076
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
K991082
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Apr 15, 1999
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
K991084
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Sep 21, 1998
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152
K982152
Phamatech
Toxicology · 95d

About Product Code DIS - Regulatory Context