Quantra QPlus System— 510(k) K201513
Substantially EquivalentHemosonics, LLC
FDA 510(k) clearance K201513 for Quantra QPlus System, Substantially Equivalent on 2020-08-21. Applicant: Hemosonics, LLC. Device class: 2.
Clearance details
- Applicant
- Hemosonics, LLC
- Product code
- Code QFR
- Device class
- Class 2
- Regulation
- 21 CFR 864.5430
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Charlottesville, VA, US
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