ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)

ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) is an FDA 510(k)-cleared medical device (K896545) manufactured by Sigma Chemical Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 1989. Regulation: 8.