Clearance Summary
ARTSMedia In Vitro Culture Medium (AM-IVC Medium) received FDA 510(k) clearance under submission number K220715, sponsored by Artsmedia Denmark Aps. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2023-02-10.
- Submission: K220715
- Applicant / Sponsor: Artsmedia Denmark Aps
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2023-02-10
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.