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Nichols Institute Diagnostics
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PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) is an FDA 510(k)-cleared medical device (K022472) 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 8, 2002. Regulation: 8.