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..
FDA 510(k) Cleared Gas Chromatography, Methamphetamine Devices (Product Code LAF)
About Product Code LAF - Regulatory Context
510(k) Submission Activity
49 total 510(k) submissions under product code LAF since 1989, with 49 receiving FDA clearance (average review time: 148 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
LAF devices are reviewed by the Toxicology panel. Browse all Toxicology devices →