
Axis-Shield Doc AS
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COATEST(R) APC(TM) RESISTANCE is an FDA 510(k)-cleared medical device (K945940) manufactured by Axis-Shield Doc AS. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 1995. Regulation: 8.