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

    GLYCO-GEL TEST KIT

    K Number: K820279 · Decision Apr 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    10
    Review Days
    65

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    Basic Information

    Device Name
    GLYCO-GEL TEST KIT
    K Number
    K820279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pierce Chemical Co.
    Date Received
    February 2, 1982
    Decision Date
    April 8, 1982
    Product Code
    LCP
    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
    LCP Assay, Glycosylated Hemoglobin

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