MICROPLATE NEONATAL GALT ASSAY

MICROPLATE NEONATAL GALT ASSAY is an FDA 510(k)-cleared medical device (K990827) manufactured by Bio-Rad. 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 April 8, 1999. Regulation: 8.