ClearanceBrief
Panels › Clinical Toxicology › Product code DIO · Class 2

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Regulation 862.3250

0510(k)s in 12 months (145 all time)
0recalls in 12 months (23 all time)
12recalls that name a 510(k)
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Top companies in DIO

Company510(k)sRecalls
Ameditech, Inc.28
Roche Diagnostic Systems, Inc.90
Syva Co.90
Branan Medical Corp.52
Microgenics Corp.61
Princeton BioMeditech Corp.70
Abbott Laboratories60
Drug Free Enterprises Inc06
OraSure Technologies, Inc.41
American Bio Medica Corp.40
Decided510(k)Device and applicantCode
Jan 27, 2022K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
Carolina Liquid Chemistries Corp.
DIO
Sep 24, 2021K211973DRI Cocaine Metabolite Assay
Microgenics Corporation
DIO
Mar 12, 2020K191638Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
Medtest DX
DIO
Jul 6, 2018K181499DRI Cocaine Metabolite Assay
Microgenics Corporation
DIO
Oct 25, 2017K170293Emit II Plus Cocaine Metabolite Assay
Siemens Healthcare Diagnostics, Inc.
DIO
Aug 15, 2017K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
Carolina Liquid Chemistries Corporation
DIO
Jun 2, 2017K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
Mp Biomedicals, LLC
DIO
Nov 18, 2016K152232Quest Diagnostics HairCheck-DT (Cocaine)
Quest Diagnostics Incorporated
DIO
Jun 27, 2016K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphet
Guangzhou Wondfo Biotech Co., Ltd., CN
DIO
Mar 18, 2016K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
Safecare Biotech (Hangzhou) Co., Ltd., CN
DIO
Jul 24, 2015K142129RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTRO
Biophor Diagnostics, Inc.
DIO
Jun 29, 2015K150925Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoyl
Immunalysis Corporation
DIO
Oct 7, 2014K142353First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
W.H.P.M., Inc.
DIO
Jul 17, 2014K141647HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
Healgen Scientific,, LLC
DIO
Nov 13, 2013K131128OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
Omega Laboratories, Inc.
DIO
Jul 31, 2013K131754WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
Guangzhou Wondfo Biotech Co., Ltd.
DIO
May 8, 2012K121166WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
Guangzhou Wondfo Biotech Co., Ltd.
DIO
May 8, 2012K113751RANDOX COCAINE METABOLITE
Randox Laboratories, Ltd., GB
DIO
Apr 11, 2012K103227ORATECT ORAL FLUID DRUG SCREEN DEVICES
Branan Medical Corporation
DIO
Feb 1, 2012K103295QUICKSCREEN COCAINE 150 SCREENING TEST
Phamatech, Inc.
DIO
Jan 23, 2012K112808OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
Omega Laboratories, Inc.
DIO
Dec 5, 2011K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
Ameditech, Inc.
DIO
Nov 22, 2011K113139LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
Lin-Zhi International, Inc.
DIO
Sep 23, 2011K112071WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
Guangzhou Wondfo Biotech Co., Ltd.
DIO
Apr 8, 2011K101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
Microgenics Corp.
DIO
Feb 11, 2011K101160ROCHE ORAL FLUID COCAINE
Roche Diagnostics
DIO
Feb 11, 2009K080436RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
Quantrx Biomedical Corporation
DIO
Dec 18, 2006K062929QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
Quest Diagnostics, Inc.
DIO
Nov 16, 2006K062123VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
Ortho-Clinical Diagnostics, Inc.
DIO
Jun 15, 2006K053422RAPIDONE-COCAINE-150 TEST
American Bio Medica Corp.
DIO
May 5, 2006K053035ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
Acro Biotech, LLC
DIO
Mar 29, 2006K050945ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
Lin-Zhi International, Inc.
DIO
Nov 18, 2005K051578IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
Immunalysis Corporation
DIO
Aug 4, 2005K050465IMMUNALYSIS COCAINE ELISA FOR HAIR
Immunalysis Corporation
DIO
Apr 18, 2005K050321ONTRAK TESTCARD 9
Varian, Inc.
DIO
Apr 7, 2004K033866CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
Lin-Zhi International, Inc.
DIO
Mar 5, 2004K040198LABONE COCAINE METABOLITE MICRO-PLATE EIA
Labone, Inc.
DIO
Feb 17, 2004K032903ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
ACON Laboratories, Inc.
DIO
Feb 9, 2004K033713URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
Dade Behring, Inc.
DIO
Dec 23, 2003K030360RANDOX EVIDENCE
Randox Laboratories, Ltd., GB
DIO
Sep 29, 2003K023626AML HAIRCHECK-DT (COCAINE)
Quest Diagnostics, Inc.
DIO
Aug 21, 2003K032057TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
Branan Medical Corp.
DIO
Jul 23, 2003K031512EMIT II PLUS COCAINE METABOLITE ASSAY
Dade Behring, Inc.
DIO
Apr 28, 2003K030234COZART EIA COCAINE ORAL FLIUD KIT
Cozart Bioscience , Ltd., GB
DIO
Dec 16, 2002K023489QUICKTOX MULTIPLE DRUG DIPCARD
Branan Medical Corp.
DIO
Dec 6, 2002K023281ONLINE DAT II COCAINE II
Roche Diagnostics Corp.
DIO
Nov 25, 2002K023296COBAS INTEGRA ONLINE DAT II COCAINE II
Roche Diagnostics Corp.
DIO
Nov 6, 2002K022954AMEDICA DRUG SCREEN COCAINE TEST
Amedica Biotech, Inc.
DIO
Jul 30, 2002K022355QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
Branan Medical Corp.
DIO
Jun 10, 2002K014069LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
Princeton BioMeditech Corp.
DIO

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