
Biopool Intl., Inc.
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BIOCLOT APC SENSITIVITY is an FDA 510(k)-cleared medical device (K983898) manufactured by Biopool Intl., Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 1999. Regulation: 8.