L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA— 510(k) K874328

Name: FDA 510(k) clearance K874328
Creator: U.S. Food and Drug Administration
Published: 1988-02-16

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K874328 for L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA, Substantially Equivalent on 1988-02-16. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code JCF
Device class: Class 1
Regulation: 21 CFR 864.8500
Advisory panel: Hematology
Date received: 1987-10-22
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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