FDA Product Code SGG: Mass Spectrometric, Immunoglobulins (g, A, M, D, E)
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.
Leading manufacturers include The Binding Site Group , Ltd..
List of Mass Spectrometric, Immunoglobulins (g, A, M, D, E) devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Mass Spectrometric, Immunoglobulins (g, A, M, D, E) devices (product code SGG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Immunology FDA review panel. Browse all Immunology devices →