ACETAMINOPHEN STAT-PAK REAGENT SET

ACETAMINOPHEN STAT-PAK REAGENT SET is an FDA 510(k)-cleared medical device (K821969) manufactured by Clin Tech Diagnostics Corp.. 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 July 15, 1982. Regulation: 8.