Product code PKM
- Device name
- Chemiluminescent Immunoassay System
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.
- Source
- FDA openFDA device classification dataset