Clearance Summary
NOVACYTE-U received FDA 510(k) clearance under submission number K862665, sponsored by Xsirius Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1986-09-04.
- Submission: K862665
- Applicant / Sponsor: Xsirius Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3250
- Decision date: 1986-09-04
Classification & Regulation
This clearance is catalogued under FDA product code KDT and 21 CFR 864.3250, within the Pathology review panel as a Class I device.