Source document or public record
FDA 510(k) K250159 — Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
FDA 510(k) index record K250159. Device: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser. Applicant as listed: The Binding Site Group , Ltd.. Decision date: 2025-10-17.
Source
"device_name": "Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K250159.
Device name: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser. Applicant as listed: The Binding Site Group , Ltd..
Decision date: 2025-10-17. Decision wording: Substantially Equivalent.
Product code: SGG. Regulation: 21 CFR 866.5510. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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