Product code DFB
- Device name
- Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5130
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823829 | FERRITIN IMMUNORADIOMETRIC ASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-03-11 |