CGM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Method, Immunodiffusion, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
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Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| HUMAN IGG SUBCLASS RID KIT (K915650) | Janssen Biochimica | 1992-03-26 | + Add |
| IL TEST IMMUNOGLOBULIN G (IGG) (K920006) | Instrumentation Laboratory CO | 1992-03-13 | + Add |
| IL TEST IMMUNOGLOBULIN M (IGM) (K920008) | Instrumentation Laboratory CO | 1992-03-11 | + Add |
| ISOTYPES HUMAN IGG SUBCLASS EIA KIT (K920370) | Isotypes, Inc. | 1992-03-11 | + Add |
Track CGM automatically
Every clearance here is in the API, with alerts when new ones post.