POMC/PCSK1/LEPR CDx Panel

POMC/PCSK1/LEPR CDx Panel is an FDA 510(k)-cleared medical device (DEN200059) manufactured by Preventiongenetics, LLC. 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 January 20, 2022. Regulation: 8.