SPIN-CHEM LD-L REAGENT

SPIN-CHEM LD-L REAGENT is an FDA 510(k)-cleared medical device (K812472) manufactured by Smithkline Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 1981. Regulation: 8.