HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT is an FDA 510(k)-cleared medical device (K970477) manufactured by Sebia. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 1997. Regulation: 8.