HYDRAGEL CSF ISOFOCUSING KITS

HYDRAGEL CSF ISOFOCUSING KITS is an FDA 510(k)-cleared medical device (K033277) manufactured by Morax. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 2003. Regulation: 8.