VITAMIN B12/FOLATE DUAL RADIOASSAY KITS

VITAMIN B12/FOLATE DUAL RADIOASSAY KITS is an FDA 510(k)-cleared medical device (K812979) manufactured by Amersham 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 November 23, 1981. Regulation: 8.