510(k) K250159 ยท SGG Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Oct 17, 2025 |
| Received | Jan 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2026 | The Binding Site Group, Ltd. Brand Name: EXENT Analyser
Product Name: EXENT Analyser
Model/Catalog Number: IE800.A
Software Version: 1.0.20
Product Description: The EXENT Analyser is an automated analyser intended for the qualita Open, Classified |
OTA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.