BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA

    K Number: K874328 · Decision Feb 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    253
    Review Days
    117

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    Basic Information

    Device Name
    L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
    K Number
    K874328
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    October 22, 1987
    Decision Date
    February 16, 1988
    Product Code
    JCF
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JCF Lymphocyte Separation Medium

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