Atlas FDA

LAF

49 FDA 510(k) clearances · Product code

89 daysmedian time to decision
383 days90th percentile
49clearances measured

FDA profile

Official device name
Gas Chromatography, Methamphetamine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3610
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (K203647)Immunalysis Corporation2021-12-22
Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (K210212)Psychemedics Corporation2021-12-15
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers (K201442)Diatron Group2020-07-31
Rapid Tox Cup II (K170222)American Bio Medica Corp.2017-08-15
Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K153693)Immunalysis Corporation2016-03-18
Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls (K142293)Biophor Diagnostics, Inc.2015-09-18
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096)Healgen Scientific,, LLC2015-03-04
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K150162)W.H.P.M., Inc.2015-02-26
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU (K133047)Biophor Diagnostics, Inc.2014-12-18
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131652)Lin-Zhi International, Inc.2014-03-21
PSYCHEMEDICS METHAMPHETAMINE EIA (K111927)Psychemedics Corp.2012-05-01
LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS (K113661)Lin-Zhi International, Inc.2012-01-23
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST (K112236)Guangzhou Wondfo Biotech Co., Ltd.2011-09-19
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) (K101973)Omega Laboratories, Inc.2011-08-16
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY (K101753)Microgenics Corp.2011-04-08
ROCHE FLUDI METHAMPHETAMINE (K093884)Roche Diagnostics2011-02-25
RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 (K080455)Quantrx Biomedical Corporation2008-12-31
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA (K080381)Quest Diagnostics, Inc.2008-06-25
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS (K062242)Lin-Zhi International, Inc.2006-09-29
IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS (K051577)Immunalysis Corporation2005-10-04
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE (K033299)ACON Laboratories, Inc.2003-12-12
LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA (K023837)Princeton BioMeditech Corp.2003-09-15
AMEDICA DRUG SCREEN METHAPHETAMINE TEST (K023101)Amedica Biotech, Inc.2002-12-16
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE (K022589)ACON Laboratories, Inc.2002-10-28
AMPHETAMINE/METHAMPHETAMINE (K012998)Abbott Laboratories2002-03-13
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE (K012585)Ameditech, Inc.2001-11-16
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE (K011672)ACON Laboratories, Inc.2001-07-31
LIVESURE METHAMPHETAMINE SCREEN TESTS (K011610)Pan Probe Biotech, Inc.2001-06-08
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY (K010496)Microgenics Corp.2001-05-29
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) (K003847)Alfa Scientific Designs, Inc.2001-05-29
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) (K003845)Alfa Scientific Designs, Inc.2001-05-29
AT WORK DRUG TEST, MODEL 9147T AWT (K010836)Phamatech2001-04-11
ESCREEN SYSTEM (K003352)Escreen, Inc.2001-03-20
FIRST CHECK HOME DRUG TEST PANEL 4 (K993852)Worldwide Medical Corp.2000-11-29
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 (K000096)Roche Diagnostics Corp.2000-04-26
SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST (K000452)Drug Detection Devices, Ltd.2000-04-24
REDI-SCREEN (K000979)Redwood Biotech, Inc.2000-04-10
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I (K993208)OraSure Technologies, Inc.2000-04-03
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 (K000447)Phamatech2000-03-07
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL (K993982)Syva Co.2000-01-27
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 (K992634)Diagnostic Products Corp.2000-01-20
AT HOME DRUG TEST, MODEL 9068 (K994233)Phamatech1999-12-30
REDI-TEST METHAMPHETAMINE (K991504)Redwood Biotech, Inc.1999-07-22
DBEST METHAMPHETAMINES TEST KIT (K983189)Ameritek, Inc.1998-11-18
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065) (K972556)Phamatech1997-09-02
ACCUSIGN MET/BIOSIGN MET (K961249)Princeton BioMeditech Corp.1996-04-25
TENONE(TM) METHAMPHETAMINE (K910043)Diagnostic Products Corp.1991-02-14
CEDIA(TM) PHENOBARBITAL ASSAY (K904413)Microgenics Corp.1990-11-05
COAT-A-COUNT METHAMPHETAMIN #TKMA1 (K885071)Diagnostic Products Corp.1989-01-09

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