SERIM BLOOD LEAK TEST STRIP-2

SERIM BLOOD LEAK TEST STRIP-2 is an FDA 510(k)-cleared medical device (K012115) manufactured by Serim Research Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 2001. Regulation: 8.