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

    SANDARE CYANMETHEMOGLOBIN REAGENT

    K Number: K792503 · Decision Dec 31, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    23
    Review Days
    27

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    Basic Information

    Device Name
    SANDARE CYANMETHEMOGLOBIN REAGENT
    K Number
    K792503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    December 4, 1979
    Decision Date
    December 31, 1979
    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 Sandare Chemical Co., Inc.

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    K842516 SANDARE ACID PHOSPHATASE PROCEDURE
    K833898 TRI-LEVEL BILIRUBIN CONTROLS
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