LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
Device Facts
| Record ID | K911731 |
|---|---|
| Device Name | LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | JCF · Hematology |
| Decision Date | Dec 15, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.