ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT is an FDA 510(k)-cleared medical device (K821554) manufactured by Amf Biological and Diagnostics Co.. 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 June 24, 1982. Regulation: 8.