Continuous Single Culture-NX Complete (CSCM-NXC)

Continuous Single Culture-NX Complete (CSCM-NXC) is an FDA 510(k)-cleared medical device (K170602) 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 6, 2017. Regulation: 8.