LABILE REMOVING HEMOLYZING REAGENT

LABILE REMOVING HEMOLYZING REAGENT is an FDA 510(k)-cleared medical device (K830804) manufactured by Corning Medical & Scientific. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 3, 1983. Regulation: 8.