
Microgenics Corp.
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CEDIA RED BLOOD CELL FOLATE REAGENT PACK is an FDA 510(k)-cleared medical device (K921689) manufactured by Microgenics 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 June 15, 1992. Regulation: 8.