510(k) K220715

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) by Artsmedia Denmark Aps — Product Code MQL

K220715 is an FDA 510(k) premarket notification submitted by Artsmedia Denmark Aps for the device "ARTSMedia In Vitro Culture Medium (AM-IVC Medium)". The FDA issued a decision of Substantially Equivalent on February 10, 2023. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Artsmedia Denmark Aps has at least 2 other 510(k) clearances on record.