
Biocheck, Inc.
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BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 is an FDA 510(k)-cleared medical device (K041619) manufactured by Biocheck, Inc.. 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 December 16, 2004. Regulation: 8.