JKF — Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge Class I

FDA Device Classification

FDA product code JKF covers "Dinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge", a Class I medical device regulated under 21 CFR 862.1380. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.