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Quantra Hemostasis Analyzer, QPlus Cartridge

DEN180017 Class II Direct
Decision Date
2019-03-12
Sponsor / Applicant
Hemosonics, LLC

Technical Specification

510(k) Submission ID DEN180017
Product Code QFR
Medical Specialty / Panel Hematology
Regulation Citation 21 CFR 864.5430
Decision Date 2019-03-12
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Quantra Hemostasis Analyzer, QPlus Cartridge received FDA 510(k) clearance under submission number DEN180017, sponsored by Hemosonics, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2019-03-12.

Classification & Regulation

This clearance is catalogued under FDA product code QFR and 21 CFR 864.5430, within the Hematology review panel as a Class II device.