COAG-CONTROL [N] KIT

COAG-CONTROL [N] KIT is an FDA 510(k)-cleared medical device (K922174) manufactured by American Bioproducts Co.. 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 25, 1992. Regulation: 8.