
Nichols Institute Diagnostics
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ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM is an FDA 510(k)-cleared medical device (K853717) manufactured by Nichols Institute Diagnostics. 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 October 1, 1985. Regulation: 8.