POSITIVE LUPUS ANTICOAGULANT PLASMA

POSITIVE LUPUS ANTICOAGULANT PLASMA is an FDA 510(k)-cleared medical device (K945856) manufactured by George King Bio-Medical, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 1995. Regulation: 8.