BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    QUANTASE PHE/GAL SCREENING ASSAY

    K Number: K984463 · Decision Feb 16, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    4
    Review Days
    62

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    Basic Information

    Device Name
    QUANTASE PHE/GAL SCREENING ASSAY
    K Number
    K984463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1555
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Quantase , Ltd.
    Date Received
    December 16, 1998
    Decision Date
    February 16, 1999
    Product Code
    JNB
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

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