Method, Immunodiffusion, Immunoglobulins (G, A, M)
The Immunodiffusion Method, Immunoglobulins (G, A, M) test system (product code CGM) is an in-vitro diagnostic device used in immunology to quantify IgG, IgA, and IgM immunoglobulins in serum using radial immunodiffusion or related immunodiffusion techniques. It is classified as FDA Class 2, representing moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 866.5510 in the Immunology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CGM
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K915650 | HUMAN IGG SUBCLASS RID KIT | Mar 26, 1992 | Substantially Equivalent | Janssen Biochimica |
| K920006 | IL TEST IMMUNOGLOBULIN G (IGG) | Mar 13, 1992 | Substantially Equivalent | Instrumentation Laboratory CO |
| K920370 | ISOTYPES HUMAN IGG SUBCLASS EIA KIT | Mar 11, 1992 | Substantially Equivalent | Isotypes, Inc. |
| K920008 | IL TEST IMMUNOGLOBULIN M (IGM) | Mar 11, 1992 | Substantially Equivalent | Instrumentation Laboratory CO |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.