
Nichols Institute Diagnostics
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NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 is an FDA 510(k)-cleared medical device (K982866) manufactured by Nichols Institute 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 October 15, 1998. Regulation: 8.