Cleared Special

Quantra Hemostasis Analyzer

K232215 · Hemosonics, LLC · Hematology
Aug 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K232215 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 August 24, 2023, 29 days after receiving the submission on July 26, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5430.

Submission Details

510(k) Number K232215 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2023
Decision Date August 24, 2023
Days to Decision 29 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.