510(k) K231804

PRIME-XV FreezIS DMSO-Free MD by Fujifilm Irvine Scientific — Product Code NDS

K231804 is an FDA 510(k) premarket notification submitted by Fujifilm Irvine Scientific for the device "PRIME-XV FreezIS DMSO-Free MD". The FDA issued a decision of Substantially Equivalent on November 9, 2023. The device falls under product code NDS (Media, Culture, Ex Vivo, Tissue And Cell), a Class II device regulated under 21 CFR 876.5885. Fujifilm Irvine Scientific has at least 4 other 510(k) clearances on record.