
Olympus Corp.
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CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED is an FDA 510(k)-cleared medical device (K910147) manufactured by Olympus 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 March 10, 1991. Regulation: 8.