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

    EZ-SCREEN: AMPHETAMINES

    K Number: K905700 · Decision Jan 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    6
    Review Days
    26

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    Basic Information

    Device Name
    EZ-SCREEN: AMPHETAMINES
    K Number
    K905700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Environmental Diagnostics, Inc.
    Date Received
    December 20, 1990
    Decision Date
    January 15, 1991
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Environmental Diagnostics, Inc.

    K Number Device Name
    K905057 EZ-SCREEN:BARBITURATES
    K902681 EZ-SCREEN:HCG
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    K883105 EZ-SCREEN CANNABINOID/COCAINE
    K862916 EZ-SCREEN: CANNABINOID