
Helena Laboratories
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CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 is an FDA 510(k)-cleared medical device (K930359) 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 April 11, 1993. Regulation: 8.