K250159
- 510(k) number
- K250159
- Device name
- Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
- Applicant
- The Binding Site Group , Ltd. GB
- Product code
- SGG — Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
- Decision date
- 2025-10-17
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K250159.pdf
Official FDA record: K250159
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.