LAF — Gas Chromatography, Methamphetamine Class II
FDA product code LAF covers "Gas Chromatography, Methamphetamine", a Class II medical device regulated under 21 CFR 862.3610. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203647 | immunalysis corporation | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | December 22, 2021 |
| K210212 | psychemedics corporation | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | December 15, 2021 |
| K201442 | diatron group | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus | July 31, 2020 |
| K170222 | american bio medica | Rapid Tox Cup II | August 15, 2017 |
| K153693 | immunalysis corporation | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal | March 18, 2016 |
| K142293 | biophor diagnostics | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methampheta | September 18, 2015 |
| K150096 | healgen scientific | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclid | March 4, 2015 |
| K150162 | w.h.p.m | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | February 26, 2015 |
| K133047 | biophor diagnostics | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET | December 18, 2014 |
| K131652 | lin-zhi international | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | March 21, 2014 |
| K111927 | psychemedics | PSYCHEMEDICS METHAMPHETAMINE EIA | May 1, 2012 |
| K113661 | lin-zhi international | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METH | January 23, 2012 |
| K112236 | guangzhou wondfo biotech co | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST | September 19, 2011 |
| K101973 | omega laboratories | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENE | August 16, 2011 |
| K101753 | microgenics | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | April 8, 2011 |
| K093884 | roche diagnostics | ROCHE FLUDI METHAMPHETAMINE | February 25, 2011 |
| K080455 | quantrx biomedical corporation | RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 | December 31, 2008 |
| K080381 | quest diagnostics | QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA | June 25, 2008 |
| K062242 | lin-zhi international | METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTR | September 29, 2006 |
| K051577 | immunalysis corporation | IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS | October 4, 2005 |