Quantra Hemostasis Analyzer, QPlus Cartridge— 510(k) DEN180017

Unknown

Hemosonics, LLC

FDA 510(k) clearance DEN180017 for Quantra Hemostasis Analyzer, QPlus Cartridge, Unknown on 2019-03-12. 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: 2018-04-02
Decision date: 2019-03-12
Decision: Unknown
Clearance type: Direct
Location: Charlottesville, VA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.