SPECTROLYSE ANTITHROMBIN III (ANTI-XA)

SPECTROLYSE ANTITHROMBIN III (ANTI-XA) is an FDA 510(k)-cleared medical device (K960871) manufactured by Medical Diagnostic Technologies, 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 August 13, 1996. Regulation: 8.