
Diazyme Laboratories
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DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET is an FDA 510(k)-cleared medical device (K131556) 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 June 25, 2013. Regulation: 8.