VARELISA TPO ANTIBODIES, MODEL 12348/12396

VARELISA TPO ANTIBODIES, MODEL 12348/12396 is an FDA 510(k)-cleared medical device (K993585) manufactured by Pharmacia & Upjohn 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 January 4, 2000. Regulation: 8.