BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HIGH DENSITY LIPOPROTEIN CHOLESTEROL

    K Number: K912823 · Decision Aug 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    65
    Applicant Total
    27
    Review Days
    51

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    Basic Information

    Device Name
    HIGH DENSITY LIPOPROTEIN CHOLESTEROL
    K Number
    K912823
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Creative Laboratory Products, Inc.
    Date Received
    June 26, 1991
    Decision Date
    August 16, 1991
    Product Code
    LBR
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LBR Ldl & Vldl Precipitation, Hdl

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    Other Clearances by Creative Laboratory Products, Inc.

    K Number Device Name
    K950589 CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL
    K942284 CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET
    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
    K912725 TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
    K904989 CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II
    Search all 27 clearances from Creative Laboratory Products, Inc. →