Clearance Summary
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well received FDA 510(k) clearance under submission number K150756, sponsored by Hertart. 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 2015-07-20.
- Submission: K150756
- Applicant / Sponsor: Hertart
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2015-07-20
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.