VITAMIN B12 (57CO) RADIOIMMUNOASSAY

VITAMIN B12 (57CO) RADIOIMMUNOASSAY is an FDA 510(k)-cleared medical device (K802220) manufactured by Corning Medical & Scientific. 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 January 8, 1981. Regulation: 8.