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

    HEMOGLOBIN REAGENT

    K Number: K821658 · Decision Jun 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    26
    Review Days
    21

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    Basic Information

    Device Name
    HEMOGLOBIN REAGENT
    K Number
    K821658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Anco Medical Reagents & Assoc.
    Date Received
    June 4, 1982
    Decision Date
    June 25, 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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    Other Clearances by Anco Medical Reagents & Assoc.

    K Number Device Name
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    K821526 ACID PHOSPHATASE REAGENT SET
    K821102 MEGNESIUM REAGENT KIT
    K820951 ENZYMATIC CHOLESTEROL KIT
    K820491 SGPT REAGENT SET
    K820500 TOTAL LIPID REAGENT SET
    K820466 SGOT REAGENT SET
    K812837 ALKALINE PHOSPHATASE REAGENT SET
    K813415 UREA NITROGEN REAGENT SET
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