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

    URINE TOXICOLOGY STANDARD

    K Number: K881320 · Decision Sep 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    14
    Review Days
    165

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    Basic Information

    Device Name
    URINE TOXICOLOGY STANDARD
    K Number
    K881320
    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
    March 28, 1988
    Decision Date
    September 9, 1988
    Product Code
    DKB
    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
    DKB Calibrators, Drug Mixture

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    Other Clearances by Verichem Laboratories, Inc.

    K Number Device Name
    K112834 MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
    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
    K875285 MULTI-CHEMISTRY LINEARITY STANDARD
    K882117 ETHYL ALCOHOL STANDARD
    Search all 14 clearances from Verichem Laboratories, Inc. →