STERICHEK BLOOD LEAK REAGENT STRIPS

STERICHEK BLOOD LEAK REAGENT STRIPS is an FDA 510(k)-cleared medical device (K042322) manufactured by Hach Company. 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 December 6, 2004. Regulation: 8.