NEONATAL TSH RIA KIT (125I)

NEONATAL TSH RIA KIT (125I) is an FDA 510(k)-cleared medical device (K772192) manufactured by Diagnostic Products Corp.. 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 January 11, 1978. Regulation: 8.