Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser— 510(k) K250159

Name: FDA 510(k) clearance K250159
Creator: U.S. Food and Drug Administration
Published: 2025-10-17

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K250159 for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser, Substantially Equivalent on 2025-10-17. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code SGG
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2025-01-21
Decision date: 2025-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K250159

K-number listed on FDA's recall record

Z-2362-2026 — 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 qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.Class II·Ongoing·The Binding Site Group, Ltd.·20260416

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K250159.

Data sourced from openFDA. This site is unofficial and independent of the FDA.