THYRO-ZYME-T4 ASSAY KIT

THYRO-ZYME-T4 ASSAY KIT is an FDA 510(k)-cleared medical device (K780401) manufactured by Coulter Electronics, 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 April 23, 1978. Regulation: 8.