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

    CYANMETHEMOGLOBIN TEST

    K Number: K820596 · Decision Mar 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    340
    Review Days
    22

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    Basic Information

    Device Name
    CYANMETHEMOGLOBIN TEST
    K Number
    K820596
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    March 4, 1982
    Decision Date
    March 26, 1982
    Product Code
    KHG
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHG Whole Blood Hemoglobin Determination

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