DCE — Fab, Antigen, Antiserum, Control Class I
FDA Device Classification
Classification Details
- Product Code
- DCE
- Device Class
- Class I
- Regulation Number
- 866.5520
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K781951 | kallestad laboratories | ANTISERA, RHODAMINE CONJUGATED FRAGMENT | February 16, 1979 |
| K772128 | kallestad laboratories | FLUORESCEIN CONJUGATED | November 22, 1977 |