SERIM BLOOD LEAK TEST STRIP

SERIM BLOOD LEAK TEST STRIP is an FDA 510(k)-cleared medical device (K990206) 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 April 20, 1999. Regulation: 8.