FDA product code CGM: Method, Immunodiffusion, Immunoglobulins (G, A, M)
CGM is the FDA product code for method, immunodiffusion, immunoglobulins (g, a, m). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under CGM, from 3 different applicants. The average 510(k) review took 70 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Method, Immunodiffusion, Immunoglobulins (G, A, M) |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CGM clearance
Top CGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 2 | 1992-03-13 |
| Janssen Biochimica | 1 | 1992-03-26 |
| Isotypes, Inc. | 1 | 1992-03-11 |
Most recent CGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K915650 | Janssen Biochimica | HUMAN IGG SUBCLASS RID KIT | 1992-03-26 | 99 |
| K920006 | Instrumentation Laboratory CO | IL TEST IMMUNOGLOBULIN G (IGG) | 1992-03-13 | 71 |
| K920370 | Isotypes, Inc. | ISOTYPES HUMAN IGG SUBCLASS EIA KIT | 1992-03-11 | 43 |
| K920008 | Instrumentation Laboratory CO | IL TEST IMMUNOGLOBULIN M (IGM) | 1992-03-11 | 69 |
Recalls for CGM devices
openFDA lists no recalls for product code CGM.
Frequently asked questions
What is FDA product code CGM?
CGM is the FDA product code for method, immunodiffusion, immunoglobulins (g, a, m). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is CGM?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CGM?
Across 4 cleared submissions the average was 70 days from receipt to decision (median 70).
Which companies have the most CGM clearances?
Instrumentation Laboratory CO (2); Janssen Biochimica (1); Isotypes, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CGM
- Run a recall and safety report across every CGM manufacturer
- Watch product code CGM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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