ATAC CALCIUM REAGENT AND ATAC CALIBRATOR

ATAC CALCIUM REAGENT AND ATAC CALIBRATOR is an FDA 510(k)-cleared medical device (K023105) manufactured by Elan 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 March 12, 2003. Regulation: 8.