SSS-NX (Serum Substitute Supplement-NX)

SSS-NX (Serum Substitute Supplement-NX) is an FDA 510(k)-cleared medical device (K233764) manufactured by Fujifilm Irvine Scientific. 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 April 23, 2024. Regulation: 8.