PEFAKIT APC-R FACTOR V LEIDEN CONTROLS

PEFAKIT APC-R FACTOR V LEIDEN CONTROLS is an FDA 510(k)-cleared medical device (K042760) manufactured by Pentapharm , 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 December 21, 2004. Regulation: 8.