MRS — Test System, Nicotine, Cotinine, Metabolites Class I

FDA Device Classification

FDA product code MRS covers "Test System, Nicotine, Cotinine, Metabolites", a Class I medical device regulated under 21 CFR 862.3220. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.