RADIOASSY KIT, 3H-FOLATE

RADIOASSY KIT, 3H-FOLATE is an FDA 510(k)-cleared medical device (K760262) manufactured by Diamond Shamrock Corp.. 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 August 2, 1976. Regulation: 8.