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

    PROTOFLUOR Z

    K Number: K871499 · Decision Aug 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    280
    Review Days
    131

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    Basic Information

    Device Name
    PROTOFLUOR Z
    K Number
    K871499
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1595
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    April 16, 1987
    Decision Date
    August 25, 1987
    Product Code
    JKJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JKJ Fluorometric Measurement, Porphyrins

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