GSP NEONATAL BIOTINIDASE KIT

GSP NEONATAL BIOTINIDASE KIT is an FDA 510(k)-cleared medical device (K131284) manufactured by Wallac OY. 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 November 13, 2013. Regulation: 8.