CGM — Method, Immunodiffusion, Immunoglobulins (G, A, M) Class II
FDA Device Classification
Classification Details
- Product Code
- CGM
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K915650 | janssen biochimica | HUMAN IGG SUBCLASS RID KIT | March 26, 1992 |
| K920006 | instrumentation laboratory | IL TEST IMMUNOGLOBULIN G (IGG) | March 13, 1992 |
| K920370 | isotypes | ISOTYPES HUMAN IGG SUBCLASS EIA KIT | March 11, 1992 |
| K920008 | instrumentation laboratory | IL TEST IMMUNOGLOBULIN M (IGM) | March 11, 1992 |