
The Dow Chemical Co.
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CREATINE KINASE MB ISOENZYME IMMUNO UV is an FDA 510(k)-cleared medical device (K810861) manufactured by The Dow Chemical Co.. 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 April 13, 1981. Regulation: 8.