
Helena Laboratories
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REP(TM) LD-2 STAT KIT, CAT. NO. 3078 is an FDA 510(k)-cleared medical device (K892818) manufactured by Helena Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 19, 1989. Regulation: 8.