MODIFIED COAG-1 PT TEST CARD

MODIFIED COAG-1 PT TEST CARD is an FDA 510(k)-cleared medical device (K903019) manufactured by Cardiovascular Diagnostic Services. 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 31, 1990. Regulation: 8.