SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED is an FDA 510(k)-cleared medical device (K041240) manufactured by Fertility Solutions, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 2004. Regulation: 8.