DGE — Igd, Rhodamine, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DGE
- 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 |
|---|
| K915838 | pb diagnostic systems | OPUS FERRITIN TEST SYSTEM | March 18, 1992 |
| K871972 | american dade | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | July 21, 1987 |