Product code JBO
- Device name
- Test, Euglobulin Lysis
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7275
- Review panel
- HE
- 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 |
|---|---|---|---|
| K831055 | HEMOGLOBIN ELECTROPHORESIS METH ON THE- | Olympus Corp. | 1983-06-08 |