HELENA ULTRA SENSITIVE CPK REAGENT/DILUE

HELENA ULTRA SENSITIVE CPK REAGENT/DILUE is an FDA 510(k)-cleared medical device (K801318) 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 July 13, 1980. Regulation: 8.