KWX — Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids Class II

FDA Device Classification

FDA product code KWX covers "Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids", a Class II medical device regulated under 21 CFR 862.1187. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.