FDA 510(k)

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

Número K: K250159 · 2025-10-17

Data da decisão2025-10-17

Código do produtoSGG

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K250159.

When did Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser receive FDA 510(k) clearance?

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

Who is the listed applicant for Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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