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 Jun 04, 2015
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
K151211
Assure Tech. Co., Ltd.
Toxicology · 29d
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 Dec 08, 2014
GenPrime Snap-Top Split Key Cup
K140665
Genprime, Inc.
Toxicology · 265d
Cleared Jun 16, 2014
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
K140215
Co-Innovation Biotech Co., Ltd.
Toxicology · 139d
Cleared May 25, 2011
RANDOX BARITURATES ASSAY
K092268
Randox Laboratories, Ltd.
Toxicology · 666d
Cleared Apr 20, 2011
UCP DRUG SCREENING TEST CUPS
K110515
Ucp Biosciences, Inc.
Chemistry · 56d
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
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
K042975
Ameditech, Inc.
Toxicology · 62d
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 Nov 03, 2004
'RAPIDTEC 4' TEST
K041712
American Bio Medica Corp.
Toxicology · 133d
Cleared May 19, 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885
Lin-Zhi International, Inc.
Toxicology · 156d
Cleared Nov 10, 2003
PROFILE -ER
K033334
Medtox Diagnostics, Inc.
Toxicology · 25d
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 Apr 25, 2002
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
K014089
Sun Biomedical Laboratories, Inc.
Toxicology · 135d
Cleared Mar 20, 2002
BARBITURATES
K012996
Abbott Laboratories
Toxicology · 195d
Cleared Mar 20, 2002
VISUALINE BARBITURATES DIPSTRIP TEST
K020136
Sun Biomedical Laboratories, Inc.
Toxicology · 64d
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

About Product Code DIS - Regulatory Context