Product code JQQ
- Device name
- Dialyzer
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2050
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K761100 | MULTI-CELL ULTRAFILTRATION SYSTEM | Amicon, Inc. | 1976-12-06 |