SGG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- FDA definition
- 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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| Record | Firm | Date |
|---|---|---|
| Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159) | The Binding Site Group , Ltd. | 2025-10-17 |
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Every clearance here is in the API, with alerts when new ones post.