PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT

PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K862447) manufactured by Pantex, Div. Bio-Analysis, 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 October 6, 1986. Regulation: 8.