NICHOLS ADVANTAGE ALDOSTERONE ASSAY

NICHOLS ADVANTAGE ALDOSTERONE ASSAY is an FDA 510(k)-cleared medical device (K050784) 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 31, 2005. Regulation: 8.