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510(k) K250159

Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser by The Binding Site Group , Ltd. — Product Code SGG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2025
Date Received
January 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods.

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