AUTODELFIA NEONATAL HTSH L KIT (B077-112)

AUTODELFIA NEONATAL HTSH L KIT (B077-112) is an FDA 510(k)-cleared medical device (K973276) manufactured by Eg &G Wallac. 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 19, 1997. Regulation: 8.