IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM

IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM is an FDA 510(k)-cleared medical device (K823567) manufactured by Syva Co.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 29, 1982. Regulation: 8.