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

    DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL

    K Number: K922387 · Decision Jul 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    45
    Applicant Total
    72
    Review Days
    56

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    Basic Information

    Device Name
    DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
    K Number
    K922387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    May 20, 1992
    Decision Date
    July 15, 1992
    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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