Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
FDA 510(k) clearance K181599 · decided 2019-03-18
Clearance details
- K-number
- K181599
- Device name
- Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
- Applicant
- Beckman Coulter
- Decision
- Substantially Equivalent
- Date received
- 2018-06-18
- Decision date
- 2019-03-18
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- QFS
- Device class
- 2
- Regulation number
- 866.3215
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.