CONTINUOUS SINGLE CULTURE COMPLETE

CONTINUOUS SINGLE CULTURE COMPLETE is an FDA 510(k)-cleared medical device (K121572) manufactured by Irvine Scientific Sales Co., Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 18, 2012. Regulation: 8.