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LAF — Gas Chromatography, Methamphetamine Class II

FDA Device Classification

Classification Details

Product Code
LAF
Device Class
Class II
Regulation Number
862.3610
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203647immunalysis corporationSEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayDecember 22, 2021
K210212psychemedics corporationPsychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairDecember 15, 2021
K201442diatron groupLin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus July 31, 2020
K170222american bio medicaRapid Tox Cup IIAugust 15, 2017
K153693immunalysis corporationImmunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalMarch 18, 2016
K142293biophor diagnosticsRapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid MethamphetaSeptember 18, 2015
K150096healgen scientificHealgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen PhencyclidMarch 4, 2015
K150162w.h.p.mFirst Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestFebruary 26, 2015
K133047biophor diagnosticsRAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRETDecember 18, 2014
K131652lin-zhi internationalLZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSMarch 21, 2014
K111927psychemedicsPSYCHEMEDICS METHAMPHETAMINE EIAMay 1, 2012
K113661lin-zhi internationalLZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHJanuary 23, 2012
K112236guangzhou wondfo biotech coWONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TESTSeptember 19, 2011
K101973omega laboratoriesOMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEAugust 16, 2011
K101753microgenicsTHERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAYApril 8, 2011
K093884roche diagnosticsROCHE FLUDI METHAMPHETAMINEFebruary 25, 2011
K080455quantrx biomedical corporationRAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050December 31, 2008
K080381quest diagnosticsQUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIAJune 25, 2008
K062242lin-zhi internationalMETHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTRSeptember 29, 2006
K051577immunalysis corporationIMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDSOctober 4, 2005