AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
Device Facts
| Record ID | K820396 |
|---|---|
| Device Name | AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR |
| Applicant | Pheragen Technology Corp. |
| Product Code | GKT · Hematology |
| Decision Date | Apr 27, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9245 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.”
