GNK — Antisera, Cf, Echovirus 1-34 Class I

FDA Device Classification

FDA product code GNK covers "Antisera, Cf, Echovirus 1-34", a Class I medical device regulated under 21 CFR 866.3205. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.