Cleared Traditional

QStat Cartridge

K213917 · Hemosonics, LLC · Hematology
Nov 2022
Decision
349d
Days
Class 2
Risk

About This 510(k) Submission

K213917 is an FDA 510(k) clearance for the QStat Cartridge, 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 November 29, 2022, 349 days after receiving the submission on December 15, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5430.

Submission Details

510(k) Number K213917 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2021
Decision Date November 29, 2022
Days to Decision 349 days
Submission Type Traditional
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.