DFB — Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control Class II
FDA product code DFB covers "Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5130. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DFB
- Device Class
- Class II
- Regulation Number
- 866.5130
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K823829 | bd becton dickinson vacutainer systems preanalytic | FERRITIN IMMUNORADIOMETRIC ASSAY KIT | March 11, 1983 |