EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME

EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME is an FDA 510(k)-cleared medical device (K890859) manufactured by Elite Diagnostic , Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 1989. Regulation: 8.