SQA V, SPERM QUALITY ANALYZER

SQA V, SPERM QUALITY ANALYZER is an FDA 510(k)-cleared medical device (K021746) manufactured by Medical Electronic Systems, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 2002. Regulation: 8.