MYT — Biosensor, Immunoassay, Cpk Or Isoenzymes Class II

FDA Device Classification

FDA product code MYT covers "Biosensor, Immunoassay, Cpk Or Isoenzymes", a Class II medical device regulated under 21 CFR 862.1215. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.