FDA Product Code LAF: Gas Chromatography, Methamphetamine
Gas chromatography provides definitive confirmation of methamphetamine in forensic and clinical samples. FDA product code LAF covers gas chromatography systems for methamphetamine quantification.
These analytical instruments separate and quantify methamphetamine and amphetamine by gas chromatographic separation followed by mass spectrometry or other detection, providing definitive confirmation after immunoassay screening.
LAF devices are Class II medical devices, regulated under 21 CFR 862.3610 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Immunalysis Corporation, Healgen Scientific, LLC and American Bio Medica Corp..
List of Gas Chromatography, Methamphetamine devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Gas Chromatography, Methamphetamine devices (product code LAF). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →