NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT

NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT is an FDA 510(k)-cleared medical device (K964635) 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 May 20, 1997. Regulation: 8.