Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application— 510(k) K181599
Substantially EquivalentBeckman Coulter
FDA 510(k) clearance K181599 for Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application, Substantially Equivalent on 2019-03-18. Applicant: Beckman Coulter.
Clearance details
- Applicant
- Beckman Coulter
- Product code
- Code QFS
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.