Cleared Special

Quantra Hemostasis Analyzer

K230461 · Hemosonics, LLC · Hematology
Mar 2023
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K230461 is an FDA 510(k) clearance for the Quantra Hemostasis Analyzer, a Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (Class II — Special Controls, product code QFR), submitted by Hemosonics, LLC (Durham, US). The FDA issued a Cleared decision on March 24, 2023, 31 days after receiving the submission on February 21, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5430.

Submission Details

510(k) Number K230461 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2023
Decision Date March 24, 2023
Days to Decision 31 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code QFR — Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5430
Definition A Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties Is An In Vitro Diagnostic Device Used To Evaluate Blood Coagulation, Fibrinolysis, Or Both, In Patients.