Continuous Single Culture -NX (CSCM-NX)

Continuous Single Culture -NX (CSCM-NX) is an FDA 510(k)-cleared medical device (K170681) 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 June 7, 2017. Regulation: 8.