HISTOPAQUE-1077
Device Facts
| Record ID | K842146 |
|---|---|
| Device Name | HISTOPAQUE-1077 |
| Applicant | Sigma Chemical Co. |
| Product Code | JCF · Hematology |
| Decision Date | Jul 27, 1984 |
| 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.