
King Diagnostics, Inc.
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KD ONE-STAGE PROTHROMBIN TIME TEST is an FDA 510(k)-cleared medical device (K883640) manufactured by King Diagnostics, 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 October 30, 1988. Regulation: 8.