Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
FDA 510(k) K181599 · Beckman Coulter
510(k) numberK181599
Submission
- Device name
- Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
- Applicant
- Beckman Coulter
Miami, FL, US - Received
- June 18, 2018
- Decision date
- March 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFS – Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Specialty
- Microbiology
An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis.
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Questions and answers
When was Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application cleared by the FDA?
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (K181599) received a 510(k) decision of Substantially Equivalent on March 18, 2019, 273 days after the submission was received.
What is the product code of K181599?
The FDA product code is QFS – Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment, a Class II (moderate risk) device regulated under 21 CFR 866.3215.