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

    AQ OPIATES (MORPHINE) TEST

    K Number: K971361 · Decision Jun 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    6
    Review Days
    56

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    Basic Information

    Device Name
    AQ OPIATES (MORPHINE) TEST
    K Number
    K971361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bionike Laboratories, Inc.
    Date Received
    April 11, 1997
    Decision Date
    June 6, 1997
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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