
Biocheck, Inc.
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BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 is an FDA 510(k)-cleared medical device (K040030) manufactured by Biocheck, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 2004. Regulation: 8.