PARATHYROID HORMONE ANALYSIS PRODUCT

PARATHYROID HORMONE ANALYSIS PRODUCT is an FDA 510(k)-cleared medical device (K840379) 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 April 3, 1984. Regulation: 8.