
Helena Laboratories
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REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 is an FDA 510(k)-cleared medical device (K896170) 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 February 15, 1990. Regulation: 8.