BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT

    K Number: K021541 · Decision Oct 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    171

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    Basic Information

    Device Name
    NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
    K Number
    K021541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1555
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perkinelmer Life Sciences
    Date Received
    May 10, 2002
    Decision Date
    October 28, 2002
    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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