Product code QKT
- Device name
- Clozapine Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.3245
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A clozapine test system is intended for the in vitro quantitative measurement of clozapine in human specimens.
- Source
- FDA openFDA device classification dataset