
Biocheck, Inc.
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BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 is an FDA 510(k)-cleared medical device (K022660) manufactured by Biocheck, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2002. Regulation: 8.