VITAMIN B12 57CO/FOLATE 125I -

VITAMIN B12 57CO/FOLATE 125I - is an FDA 510(k)-cleared medical device (K840462) 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 June 24, 1984. Regulation: 8.