PKG · Bone Marrow Processing Device To Support Hematopoietic Reconstitution
Hematology · 21 CFR 864.9245 · Class 2
Overview
| Product Code | PKG |
|---|---|
| Device Name | Bone Marrow Processing Device To Support Hematopoietic Reconstitution |
| Regulation | 21 CFR 864.9245 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
An automated blood cell separator is a device that uses a centrifugal or filtration separation principle to automatically withdraw whole blood from a donor, separate the whole blood into blood components, collect one or more of the blood components, and return to the donor the remainder of the whole blood and blood components. The automated blood cell separator device is intended for routine collection of blood and blood components for transfusion or further manufacturing use.
Classification Rationale
Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is a guidance for industry and FDA staff entitled “Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.”
Recent Cleared Devices (0 of 0)
No cleared devices on record.
