The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for L-phenylalanine Methyl Ester Hydrochloride Pme Rea.
| Device ID | K874328 |
| 510k Number | K874328 |
| Device Name: | L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA |
| Classification | Lymphocyte Separation Medium |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Edward R Kimmelman |
| Correspondent | Edward R Kimmelman E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-22 |
| Decision Date | 1988-02-16 |