Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

QBV · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2050

Classification

FDA Product Code: QBV
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 862.2050
Review panel: HE
Medical specialty: Clinical Chemistry
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 14

Source

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