510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QFRClass II

Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

21 CFR 864.5430 / Hematology
FDA source (opens on fda.gov)

QFR is the FDA product code for Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties, a class II device type, regulated under 21 CFR 864.5430. FDA's definition for this code reads: "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". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QFR
Device name
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
FDA 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.
Regulation
21 CFR 864.5430
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code QFR

By decision year
8 clearances under product code QFR with a decision year between 2019 and 2025, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QFR by decision year
YearClearances
20191
20201
20222
20232
20241
20251

Applicants with the most clearances

Product code QFR
Applicants holding the most 510(k) clearances under product code QFR
ApplicantClearances
Hemosonics, LLC8

Companies listing this code with FDA

Companies whose registered establishments list this code