LDN — Enzymatic Radiochemical Assay, Amikacin Class II

FDA Device Classification

FDA product code LDN covers "Enzymatic Radiochemical Assay, Amikacin", a Class II medical device regulated under 21 CFR 862.3035. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.