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

    HEMOGLOBIN REAGENT SET

    K Number: K821202 · Decision May 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    21
    Review Days
    27

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    Basic Information

    Device Name
    HEMOGLOBIN REAGENT SET
    K Number
    K821202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Omega Medical Electronics
    Date Received
    April 27, 1982
    Decision Date
    May 24, 1982
    Product Code
    GKK
    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
    GKK Cyanomethemoglobin

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