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

    AUTO-LYTE COTININE EIA

    K Number: K972481 · Decision Oct 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    30
    Review Days
    111

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    Basic Information

    Device Name
    AUTO-LYTE COTININE EIA
    K Number
    K972481
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OraSure Technologies, Inc.
    Date Received
    July 2, 1997
    Decision Date
    October 21, 1997
    Product Code
    MKU
    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
    MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites

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