Clearance Summary
OncoMate MSI Dx Analysis System received FDA 510(k) clearance under submission number K200129, sponsored by Promega Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2021-07-26.
- Submission: K200129
- Applicant / Sponsor: Promega Corporation
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 864.1866
- Decision date: 2021-07-26
Classification & Regulation
This clearance is catalogued under FDA product code PZJ and 21 CFR 864.1866, within the Immunology review panel as a Class II device.