
Corning Medical & Scientific
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NO-BOIL VITABIN B12 5760 FOLATE 125I is an FDA 510(k)-cleared medical device (K813183) 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 March 4, 1982. Regulation: 8.