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

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..

Clearance details

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

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