Product code DHY
- Device name
- Ng4m(A), Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.5065
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K810871 | LIGHTNING DIALYZER | Clintox Laboratories, Inc. | 1981-07-10 |