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FDA PRODUCT CODE · CLASS II

QFR — Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 864.5430
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
HE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K251404Hemosonics, LLC · 510k2025-08-25

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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