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..
1
Total
1
Cleared
269d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Mass Spectrometric, Immunoglobulins (g, A, M, D, E) Devices (Product Code SGG)
1 devices
About Product Code SGG - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SGG since 2025, with 1 receiving FDA clearance (average review time: 269 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.