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

    MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT

    K Number: K903993 · Decision Dec 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    37
    Review Days
    113

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    Basic Information

    Device Name
    MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
    K Number
    K903993
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Immunotech Corp.
    Date Received
    August 29, 1990
    Decision Date
    December 20, 1990
    Product Code
    DKZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DKZ Enzyme Immunoassay, Amphetamine

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