510(k) K250159
- Device
- Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
- Applicant
- The Binding Site Group , Ltd.
- 510(k) number
- K250159
- Product code
- SGG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-17
- Date received
- 2025-01-21
- Regulation
- 866.5510
- Classification name
- Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jolanta Wolff
- Address
- 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT
FDA Registration Numbers#
- 3012471076
- 9614373