HYDRAGEL 15 HB A1C KIT

HYDRAGEL 15 HB A1C KIT is an FDA 510(k)-cleared medical device (K963844) manufactured by Morax. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 1997. Regulation: 8.