
Bio/Data Corp.
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MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP is an FDA 510(k)-cleared medical device (K860342) manufactured by Bio/Data Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 1986. Regulation: 8.