Clearance Summary
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA received FDA 510(k) clearance under submission number K874328, sponsored by E.I. Dupont DE Nemours & Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1988-02-16.
- Submission: K874328
- Applicant / Sponsor: E.I. Dupont DE Nemours & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.8500
- Decision date: 1988-02-16
Classification & Regulation
This clearance is catalogued under FDA product code JCF and 21 CFR 864.8500, within the Hematology review panel as a Class I device.