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

    PRECISET DAT PLUS

    K Number: K021393 · Decision Jun 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    38
    Review Days
    42

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    Basic Information

    Device Name
    PRECISET DAT PLUS
    K Number
    K021393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantimetrix Corp.
    Date Received
    May 2, 2002
    Decision Date
    June 13, 2002
    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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    K062942 QUANTIMETRIX NICOSURE COTININE URINE CONTROL
    K062751 MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
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    K032791 GLYCOHEMOSURE HBA1C CONTROL
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