GDS ENZYMATIC SALICYLATE REAGENT

GDS ENZYMATIC SALICYLATE REAGENT is an FDA 510(k)-cleared medical device (K882038) manufactured by Gds Technology, LLC. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 1988. Regulation: 8.