Cleared Special

Quantra QPlus System

K201513 · Hemosonics, LLC · Hematology
Aug 2020
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K201513 is an FDA 510(k) clearance for the Quantra QPlus System, a Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (Class II — Special Controls, product code QFR), submitted by Hemosonics, LLC (Charlottesville, US). The FDA issued a Cleared decision on August 21, 2020, 74 days after receiving the submission on June 8, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5430.

Submission Details

510(k) Number K201513 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2020
Decision Date August 21, 2020
Days to Decision 74 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.