GENERAL SEMEN ANALYSIS (GSA) KIT

GENERAL SEMEN ANALYSIS (GSA) KIT is an FDA 510(k)-cleared medical device (K024337) manufactured by Bioshaf , Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 2, 2003. Regulation: 8.