
Helena Laboratories
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REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 is an FDA 510(k)-cleared medical device (K892424) manufactured by Helena Laboratories. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 1989. Regulation: 8.