INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)

INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) is an FDA 510(k)-cleared medical device (K954418) 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 November 2, 1995. Regulation: 8.