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Diazyme Laboratories
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DIAZYME POTASSIUM ENZYMATIC ASSAY KIT is an FDA 510(k)-cleared medical device (K042191) manufactured by Diazyme 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 October 28, 2004. Regulation: 8.