JKL — Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry Class I

FDA Device Classification

FDA product code JKL covers "Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry", a Class I medical device regulated under 21 CFR 862.1060. Submissions are reviewed by the Clinical Chemistry panel. At least 2 recent 510(k) clearances have been granted under this product code.