Cleared Special

QStat Cartridge

K240045 · Hemosonics, LLC · Hematology
Mar 2024
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K240045 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 (Durham, US). The FDA issued a Cleared decision on March 27, 2024, 82 days after receiving the submission on January 5, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5430.

Submission Details

510(k) Number K240045 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2024
Decision Date March 27, 2024
Days to Decision 82 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.