BIO-RAD CODA NEONATAL GALT ASSAY

BIO-RAD CODA NEONATAL GALT ASSAY is an FDA 510(k)-cleared medical device (K993536) 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 November 3, 1999. Regulation: 8.