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510(k) K874328

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1988
Date Received
October 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lymphocyte Separation Medium
Device Class
Class I
Regulation Number
864.8500
Review Panel
HE
Submission Type

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