SQA, SPERM QUALITY ANALYZER

SQA, SPERM QUALITY ANALYZER is an FDA 510(k)-cleared medical device (K012352) 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 20, 2001. Regulation: 8.