Clearance Summary
Human IgM Kit for use on SPAPlus received FDA 510(k) clearance under submission number K191465, sponsored by The Binding Site Group , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2019-06-27.
- Submission: K191465
- Applicant / Sponsor: The Binding Site Group , Ltd.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2019-06-27
Classification & Regulation
This clearance is catalogued under FDA product code CFN and 21 CFR 866.5510, within the Immunology review panel as a Class II device.