CFG — Oil Emulsion/Thymolphthalein (Titrimetric), Lipase Class I

FDA Device Classification

FDA product code CFG covers "Oil Emulsion/Thymolphthalein (Titrimetric), Lipase", a Class I medical device regulated under 21 CFR 862.1465. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.