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

    ETHYL ALCOHOL STANDARD

    K Number: K882117 · Decision Aug 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    6
    Applicant Total
    14
    Review Days
    77

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    Basic Information

    Device Name
    ETHYL ALCOHOL STANDARD
    K Number
    K882117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Verichem Laboratories, Inc.
    Date Received
    May 19, 1988
    Decision Date
    August 4, 1988
    Product Code
    DNN
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DNN Calibrators, Ethyl Alcohol

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    Other Clearances by Verichem Laboratories, Inc.

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    K974290 MICROPROTEIN STANDARD KIT
    K973345 MATRIX PLUS MULTI-CALIBRATOR KIT
    K972333 AMMONIA/IRON STANDARD KIT
    K924904 HDL-CHOLESTEROL STANDARD, MODIFICATION
    K912513 ELECTROLYTE CONTROL
    K901113 MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
    K882059 BILIRUBIN STANDARD
    K881320 URINE TOXICOLOGY STANDARD
    K875285 MULTI-CHEMISTRY LINEARITY STANDARD
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