DIAZYME HOMOCYSTEINE POC TEST KIT

DIAZYME HOMOCYSTEINE POC TEST KIT is an FDA 510(k)-cleared medical device (K121053) 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 July 30, 2012. Regulation: 8.