
Helena Laboratories
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SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 is an FDA 510(k)-cleared medical device (K941872) 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 November 20, 1994. Regulation: 8.