FDA 510(k) Applications for Medical Device Product Code "LAF"
(Gas Chromatography, Methamphetamine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K012998 | ABBOTT LABORATORIES | AMPHETAMINE/METHAMPHETAMINE | 03/13/2002 |
| K033299 | ACON LABORATORIES, INC. | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE | 12/12/2003 |
| K011672 | ACON LABORATORIES, INC. | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE | 07/31/2001 |
| K022589 | ACON LABORATORIES, INC. | ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE | 10/28/2002 |
| K003845 | ALFA SCIENTIFIC DESIGNS, INC. | MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) | 05/29/2001 |
| K003847 | ALFA SCIENTIFIC DESIGNS, INC. | MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) | 05/29/2001 |
| K023101 | AMEDICA BIOTECH, INC. | AMEDICA DRUG SCREEN METHAPHETAMINE TEST | 12/16/2002 |
| K012585 | AMEDITECH, INC. | AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE | 11/16/2001 |
| K170222 | AMERICAN BIO MEDICA CORP. | Rapid Tox Cup II | 08/15/2017 |
| K983189 | AMERITEK, INC. | DBEST METHAMPHETAMINES TEST KIT | 11/18/1998 |
| K133047 | BIOPHOR DIAGNOSTICS, INC. | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU | 12/18/2014 |
| K142293 | BIOPHOR DIAGNOSTICS, INC. | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls | 09/18/2015 |
| K992634 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 | 01/20/2000 |
| K201442 | Diatron Group | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers | 07/31/2020 |
| K000452 | DRUG DETECTION DEVICES, LTD. | SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST | 04/24/2000 |
| K003352 | ESCREEN, INC. | ESCREEN SYSTEM | 03/20/2001 |
| K112236 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST | 09/19/2011 |
| K150096 | HEALGEN SCIENTIFIC LLC | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) | 03/04/2015 |
| K051577 | Immunalysis Corporation | IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS | 10/04/2005 |
| K153693 | IMMUNALYSIS CORPORATION | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | 03/18/2016 |
| K203647 | Immunalysis Corporation | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | 12/22/2021 |
| K113661 | Lin-Zhi International, Inc. | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | 01/23/2012 |
| K131652 | Lin-Zhi International, Inc. | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | 03/21/2014 |
| K062242 | Lin-Zhi International, Inc. | METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS | 09/29/2006 |
| K010496 | MICROGENICS CORP. | CEDIA DAU AMPHETAMINES/ECSTASY ASSAY | 05/29/2001 |
| K101753 | MICROGENICS CORP. | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | 04/08/2011 |
| K101973 | OMEGA LABORATORIES, INC. | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) | 08/16/2011 |
| K993208 | ORASURE TECHNOLOGIES, INC. | STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I | 04/03/2000 |
| K011610 | PAN PROBE BIOTECH, INC. | LIVESURE METHAMPHETAMINE SCREEN TESTS | 06/08/2001 |
| K994233 | PHAMATECH | AT HOME DRUG TEST, MODEL 9068 | 12/30/1999 |
| K010836 | PHAMATECH | AT WORK DRUG TEST, MODEL 9147T AWT | 04/11/2001 |
| K000447 | PHAMATECH | QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 | 03/07/2000 |
| K972556 | PHAMATECH | QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065) | 09/02/1997 |
| K961249 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN MET/BIOSIGN MET | 04/25/1996 |
| K023837 | PRINCETON BIOMEDITECH CORP. | LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA | 09/15/2003 |
| K111927 | PSYCHEMEDICS CORP. | PSYCHEMEDICS METHAMPHETAMINE EIA | 05/01/2012 |
| K210212 | Psychemedics Corporation | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | 12/15/2021 |
| K080455 | QUANTRX BIOMEDICAL CORPORATION | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 | 12/31/2008 |
| K080381 | QUEST DIAGNOSTICS, INC. | QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA | 06/25/2008 |
| K000979 | REDWOOD BIOTECH, INC. | REDI-SCREEN | 04/10/2000 |
| K991504 | REDWOOD BIOTECH, INC. | REDI-TEST METHAMPHETAMINE | 07/22/1999 |
| K093884 | Roche Diagnostics | ROCHE FLUDI METHAMPHETAMINE | 02/25/2011 |
| K000096 | ROCHE DIAGNOSTICS CORP. | ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 | 04/26/2000 |
| K993982 | SYVA CO. | SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL | 01/27/2000 |
| K150162 | W.H.P.M., Inc. | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | 02/26/2015 |
| K993852 | WORLDWIDE MEDICAL CORP. | FIRST CHECK HOME DRUG TEST PANEL 4 | 11/29/2000 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
