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DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites Class II

FDA Device Classification

Classification Details

Product Code
DIO
Device Class
Class II
Regulation Number
862.3250
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K213211carolina liquid chemistriesCarolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (CJanuary 27, 2022
K211973microgenics corporationDRI Cocaine Metabolite AssaySeptember 24, 2021
K191638medtest dxPointe Scientific Cocaine Metabolite Enzyme ImmunoassayMarch 12, 2020
K181499microgenics corporationDRI Cocaine Metabolite AssayJuly 6, 2018
K170293siemens healthcare diagnosticsEmit II Plus Cocaine Metabolite AssayOctober 25, 2017
K163570carolina liquid chemistries corporationCarolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)August 15, 2017
K162395mp biomedicalsMP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupJune 2, 2017
K152232quest diagnostics incorporatedQuest Diagnostics HairCheck-DT (Cocaine)November 18, 2016
K161214guangzhou wondfo biotech coWondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test June 27, 2016
K153646safecare biotech (hangzhou) coSAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine TesMarch 18, 2016
K142129biophor diagnosticsRAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR July 24, 2015
K150925immunalysis corporationImmunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis BenzoylecgoninJune 29, 2015
K142353w.h.p.mFirst Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestOctober 7, 2014
K141647healgen scientificHEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP July 17, 2014
K131128omega laboratoriesOMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITESNovember 13, 2013
K131754guangzhou wondfo biotech coWONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)July 31, 2013
K121166guangzhou wondfo biotech coWONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANELMay 8, 2012
K113751randox laboratoriesRANDOX COCAINE METABOLITEMay 8, 2012
K103227branan medical corporationORATECT ORAL FLUID DRUG SCREEN DEVICESApril 11, 2012
K103295phamatechQUICKSCREEN COCAINE 150 SCREENING TESTFebruary 1, 2012