Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

QFR · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5430

Classification

FDA Product Code: QFR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.5430
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 8
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown