DAC-CEL PTH KIT RD51

DAC-CEL PTH KIT RD51 is an FDA 510(k)-cleared medical device (K831069) manufactured by Wellcome 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 June 15, 1983. Regulation: 8.