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

    CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER

    K Number: K896334 · Decision Dec 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    27
    Review Days
    38

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    Basic Information

    Device Name
    CLP GLYCOSYLATED HEMOGLOBIN CONTROL-ER
    K Number
    K896334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Creative Laboratory Products, Inc.
    Date Received
    November 3, 1989
    Decision Date
    December 11, 1989
    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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    Other Clearances by Creative Laboratory Products, Inc.

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    K922995 LIPID CONTROLS
    K913427 SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
    K913371 TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
    K913585 LIPASE LINEARITY CONTROL
    K913224 LIPID LINEARITY CONTROLS
    K913496 CHOLINESTERASE LINEARITY CONTROL
    K912823 HIGH DENSITY LIPOPROTEIN CHOLESTEROL
    K912725 TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
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