GDS ENZYMATIC ACETAMINOPHEN REAGENT

GDS ENZYMATIC ACETAMINOPHEN REAGENT is an FDA 510(k)-cleared medical device (K880829) 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 May 26, 1988. Regulation: 8.