HEPARIN CONTROL PLASMA LEVEL 1

HEPARIN CONTROL PLASMA LEVEL 1 is an FDA 510(k)-cleared medical device (K992278) manufactured by Pacific Hemostasis. 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 25, 1999. Regulation: 8.