L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
Device Facts
| Record ID | K874328 |
|---|---|
| Device Name | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | JCF · Hematology |
| Decision Date | Feb 16, 1988 |
| 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.