Panels › Clinical Toxicology › Product code LAF · Class 2
Gas Chromatography, Methamphetamine
Regulation 862.3610
0510(k)s in 12 months (49 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LAF
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2021 | K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay Immunalysis Corporation | LAF |
| Dec 15, 2021 | K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair Psychemedics Corporation | LAF |
| Jul 31, 2020 | K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers Diatron Group | LAF |
| Aug 15, 2017 | K170222 | Rapid Tox Cup II American Bio Medica Corp. | LAF |
| Mar 18, 2016 | K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation | LAF |
| Sep 18, 2015 | K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid M Biophor Diagnostics, Inc. | LAF |
| Mar 4, 2015 | K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card Healgen Scientific,, LLC | LAF |
| Feb 26, 2015 | K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., Inc. | LAF |
| Dec 18, 2014 | K133047 | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU Biophor Diagnostics, Inc. | LAF |
| Mar 21, 2014 | K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS Lin-Zhi International, Inc. | LAF |
| May 1, 2012 | K111927 | PSYCHEMEDICS METHAMPHETAMINE EIA Psychemedics Corp. | LAF |
| Jan 23, 2012 | K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS Lin-Zhi International, Inc. | LAF |
| Sep 19, 2011 | K112236 | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | LAF |
| Aug 16, 2011 | K101973 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) Omega Laboratories, Inc. | LAF |
| Apr 8, 2011 | K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY Microgenics Corp. | LAF |
| Feb 25, 2011 | K093884 | ROCHE FLUDI METHAMPHETAMINE Roche Diagnostics | LAF |
| Dec 31, 2008 | K080455 | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 Quantrx Biomedical Corporation | LAF |
| Jun 25, 2008 | K080381 | QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA Quest Diagnostics, Inc. | LAF |
| Sep 29, 2006 | K062242 | METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. | LAF |
| Oct 4, 2005 | K051577 | IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation | LAF |
| Dec 12, 2003 | K033299 | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE ACON Laboratories, Inc. | LAF |
| Sep 15, 2003 | K023837 | LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA Princeton BioMeditech Corp. | LAF |
| Dec 16, 2002 | K023101 | AMEDICA DRUG SCREEN METHAPHETAMINE TEST Amedica Biotech, Inc. | LAF |
| Oct 28, 2002 | K022589 | ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE ACON Laboratories, Inc. | LAF |
| Mar 13, 2002 | K012998 | AMPHETAMINE/METHAMPHETAMINE Abbott Laboratories | LAF |
| Nov 16, 2001 | K012585 | AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE Ameditech, Inc. | LAF |
| Jul 31, 2001 | K011672 | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE ACON Laboratories, Inc. | LAF |
| Jun 8, 2001 | K011610 | LIVESURE METHAMPHETAMINE SCREEN TESTS Pan Probe Biotech, Inc. | LAF |
| May 29, 2001 | K010496 | CEDIA DAU AMPHETAMINES/ECSTASY ASSAY Microgenics Corp. | LAF |
| May 29, 2001 | K003847 | MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) Alfa Scientific Designs, Inc. | LAF |
| May 29, 2001 | K003845 | MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) Alfa Scientific Designs, Inc. | LAF |
| Apr 11, 2001 | K010836 | AT WORK DRUG TEST, MODEL 9147T AWT Phamatech | LAF |
| Mar 20, 2001 | K003352 | ESCREEN SYSTEM Escreen, Inc. | LAF |
| Nov 29, 2000 | K993852 | FIRST CHECK HOME DRUG TEST PANEL 4 Worldwide Medical Corp. | LAF |
| Apr 26, 2000 | K000096 | ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 Roche Diagnostics Corp. | LAF |
| Apr 24, 2000 | K000452 | SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST Drug Detection Devices, Ltd. | LAF |
| Apr 10, 2000 | K000979 | REDI-SCREEN Redwood Biotech, Inc. | LAF |
| Apr 3, 2000 | K993208 | STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I OraSure Technologies, Inc. | LAF |
| Mar 7, 2000 | K000447 | QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 Phamatech | LAF |
| Jan 27, 2000 | K993982 | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL Syva Co. | LAF |
| Jan 20, 2000 | K992634 | IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 Diagnostic Products Corp. | LAF |
| Dec 30, 1999 | K994233 | AT HOME DRUG TEST, MODEL 9068 Phamatech | LAF |
| Jul 22, 1999 | K991504 | REDI-TEST METHAMPHETAMINE Redwood Biotech, Inc. | LAF |
| Nov 18, 1998 | K983189 | DBEST METHAMPHETAMINES TEST KIT Ameritek, Inc. | LAF |
| Sep 2, 1997 | K972556 | QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065) Phamatech | LAF |
| Apr 25, 1996 | K961249 | ACCUSIGN MET/BIOSIGN MET Princeton BioMeditech Corp. | LAF |
| Feb 14, 1991 | K910043 | TENONE(TM) METHAMPHETAMINE Diagnostic Products Corp. | LAF |
| Nov 5, 1990 | K904413 | CEDIA(TM) PHENOBARBITAL ASSAY Microgenics Corp. | LAF |
| Jan 9, 1989 | K885071 | COAT-A-COUNT METHAMPHETAMIN #TKMA1 Diagnostic Products Corp. | LAF |
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