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Diagnon Corp.
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DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA is an FDA 510(k)-cleared medical device (K851377) manufactured by Diagnon 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 20, 1985. Regulation: 8.