STA-COAG CONTROL [P] PLUS KIT

STA-COAG CONTROL [P] PLUS KIT is an FDA 510(k)-cleared medical device (K952338) 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 September 20, 1995. Regulation: 8.