COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY

COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY is an FDA 510(k)-cleared medical device (K901874) manufactured by Kabi Diagnostica. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 1990. Regulation: 8.