Product code JBE
- Device name
- Cell Enzymes (Erythrocytic And Leukocytic)
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7100
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset