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

    EZ-SCREEN:OPIATES

    K Number: K900203 · Decision Mar 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    6
    Review Days
    52

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    Basic Information

    Device Name
    EZ-SCREEN:OPIATES
    K Number
    K900203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Environmental Diagnostics, Inc.
    Date Received
    January 16, 1990
    Decision Date
    March 9, 1990
    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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    Other Clearances by Environmental Diagnostics, Inc.

    K Number Device Name
    K905700 EZ-SCREEN: AMPHETAMINES
    K905057 EZ-SCREEN:BARBITURATES
    K902681 EZ-SCREEN:HCG
    K883105 EZ-SCREEN CANNABINOID/COCAINE
    K862916 EZ-SCREEN: CANNABINOID