LYMPHO SEP(TM)
Device Facts
| Record ID | K902445 |
|---|---|
| Device Name | LYMPHO SEP(TM) |
| Applicant | Icn Biomedicals, Inc. |
| Product Code | JCF · Hematology |
| Decision Date | Aug 22, 1990 |
| 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.