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Helena Laboratories
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ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 is an FDA 510(k)-cleared medical device (K020914) manufactured by Helena Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 2002. Regulation: 8.