JLB — Atp And Creatine Kinase (Enzymatic), Creatine Class I

FDA Device Classification

FDA product code JLB covers "Atp And Creatine Kinase (Enzymatic), Creatine", a Class I medical device regulated under 21 CFR 862.1210. Submissions are reviewed by the Clinical Chemistry panel. At least 3 recent 510(k) clearances have been granted under this product code.