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

    MODIFICATION TO PROFILE -II

    K Number: K002776 · Decision Sep 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    22
    Review Days
    22

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    Basic Information

    Device Name
    MODIFICATION TO PROFILE -II
    K Number
    K002776
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtox Diagnostics, Inc.
    Date Received
    September 6, 2000
    Decision Date
    September 28, 2000
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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    K080635 MEDTOXSCAN
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    K050394 SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
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