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American Diagnostica, Inc.
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SPECTROLYSE PAI-1, MODEL 101201 is an FDA 510(k)-cleared medical device (K063323) manufactured by American Diagnostica, 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 August 14, 2007. Regulation: 8.