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

    TINAQUANT MYOGLOBIN ASSAY

    K Number: K972513 · Decision Jul 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    45
    Applicant Total
    340
    Review Days
    21

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    Basic Information

    Device Name
    TINAQUANT MYOGLOBIN ASSAY
    K Number
    K972513
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    July 7, 1997
    Decision Date
    July 28, 1997
    Product Code
    DDR
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DDR Myoglobin, Antigen, Antiserum, Control

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