
Kem Medical Products Corp.
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CHEMICAL INDICATOR - KEM MED & BIO SURE is an FDA 510(k)-cleared medical device (K802229) manufactured by Kem Medical Products Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 1980. Regulation: 8.

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