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FDA 510(k)

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser

K-Number: K250159 · 2025-10-17

ApplicantThe Binding Site Group , Ltd.
Decision Date2025-10-17
Product CodeSGG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2025-10-17 under approval number K250159. The device is classified under product code SGG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is a medical device that received FDA 510(k) clearance on 2025-10-17. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K250159.

When was Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser approved by the FDA?

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser received FDA 510(k) clearance on 2025-10-17, under approval number K250159.

What company makes Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is manufactured by The Binding Site Group , Ltd..

What is the FDA product code for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

The FDA product code for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser is SGG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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