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

    QUANTASE PHENYLALANINE ASSAY

    K Number: K961515 · Decision Jun 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    27
    Review Days
    63

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    Basic Information

    Device Name
    QUANTASE PHENYLALANINE ASSAY
    K Number
    K961515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1555
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shield Diagnostics, Ltd.
    Date Received
    April 10, 1996
    Decision Date
    June 12, 1996
    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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