FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
Device Facts
| Record ID | K904795 |
|---|---|
| Device Name | FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | GKH · Hematology |
| Decision Date | Dec 31, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.
