ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS

ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS is an FDA 510(k)-cleared medical device (K052407) manufactured by Fisher Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 2006. Regulation: 8.