QBV

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

Product code

QBV

Device name

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

Device class

Class 1

21 CFR

21 CFR 862.2050

Medical specialty

Clinical Chemistry

Marketing pathway

510(K) Exempt

Flag

Third-party review eligible

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-04-02.

2 summaries are archived here for direct download.