MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 is an FDA 510(k)-cleared medical device (K082227) manufactured by Sebia. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2009. Regulation: 8.