BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    RAMP MYOGLOBIN ASSAY

    K Number: K012040 · Decision Dec 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    45
    Applicant Total
    7
    Review Days
    172

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    Basic Information

    Device Name
    RAMP MYOGLOBIN ASSAY
    K Number
    K012040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5680
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Response Biomedical Corp.
    Date Received
    June 29, 2001
    Decision Date
    December 18, 2001
    Product Code
    DDR
    Advisory Committee
    Immunology
    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
    DDR Myoglobin, Antigen, Antiserum, Control

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    Other Clearances by Response Biomedical Corp.

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