CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT

CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT is an FDA 510(k)-cleared medical device (K962033) 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 September 26, 1996. Regulation: 8.