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FDA 510(k)

ARTSMedia In Vitro Culture Medium (AM-IVC Medium)

K-Number: K220715 · 2023-02-10

ApplicantArtsmedia Denmark Aps
Decision Date2023-02-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medical device manufactured by Artsmedia Denmark Aps. It received FDA 510(k) clearance on 2023-02-10 under approval number K220715. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTSMedia In Vitro Culture Medium (AM-IVC Medium)?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Artsmedia Denmark Aps. The 510(k) number is K220715.

When was ARTSMedia In Vitro Culture Medium (AM-IVC Medium) approved by the FDA?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) received FDA 510(k) clearance on 2023-02-10, under approval number K220715.

What company makes ARTSMedia In Vitro Culture Medium (AM-IVC Medium)?

ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is manufactured by Artsmedia Denmark Aps.

What is the FDA product code for ARTSMedia In Vitro Culture Medium (AM-IVC Medium)?

The FDA product code for ARTSMedia In Vitro Culture Medium (AM-IVC Medium) is MQL.

Related Clinical Trials

NCT07101562 Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Avascular Necrosis of Femur Head RECRUITING NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Artsmedia Denmark Aps

K241132ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) K241095ARTSMedia Semen Wash Medium

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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