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

    AQ ONE STEP COCAINE TEST

    K Number: K972384 · Decision Aug 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    6
    Review Days
    41

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    Basic Information

    Device Name
    AQ ONE STEP COCAINE TEST
    K Number
    K972384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bionike Laboratories, Inc.
    Date Received
    June 26, 1997
    Decision Date
    August 6, 1997
    Product Code
    DIO
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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    Other Clearances by Bionike Laboratories, Inc.

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