Quantra Hemostasis Analyzer— 510(k) K230461

Substantially Equivalent

Hemosonics, LLC

FDA 510(k) clearance K230461 for Quantra Hemostasis Analyzer, Substantially Equivalent on 2023-03-24. Applicant: Hemosonics, LLC.

Clearance details

Applicant
Hemosonics, LLC
Product code
Code QFR
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Durham, NC, US
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