SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT

SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT is an FDA 510(k)-cleared medical device (K102643) manufactured by Astoria-Pacific, Inc.. 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 14, 2011. Regulation: 8.