IMMUCHEM NEONATAL TSH-MP ELISA

IMMUCHEM NEONATAL TSH-MP ELISA is an FDA 510(k)-cleared medical device (K913963) manufactured by Icn Biomedicals, 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 December 12, 1991. Regulation: 8.