DKD — Bacillus Subtilis, Microbiological Assay, Gentamicin Class II

FDA Device Classification

FDA product code DKD covers "Bacillus Subtilis, Microbiological Assay, Gentamicin", a Class II medical device regulated under 21 CFR 862.3450. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.