VISTA THYROXINE (T-4) ASSAY -- MODIFICATION

VISTA THYROXINE (T-4) ASSAY -- MODIFICATION is an FDA 510(k)-cleared medical device (K922433) manufactured by Syva 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 September 17, 1992. Regulation: 8.