510(k) K874328

L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA by E.I. Dupont DE Nemours & Co., Inc. — Product Code JCF

K874328 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA". The FDA issued a decision of Substantially Equivalent on February 16, 1988. The device falls under product code JCF (Lymphocyte Separation Medium), a Class I device regulated under 21 CFR 864.8500. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.