Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
K-Number: K250159 · 2025-10-17
Device Summary
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. 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.
Other records listing The Binding Site Group , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.