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

    FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)

    K Number: K020869 · Decision Jun 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    5
    Review Days
    85

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    Basic Information

    Device Name
    FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
    K Number
    K020869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Worldwide Medical Corp.
    Date Received
    March 18, 2002
    Decision Date
    June 11, 2002
    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 Worldwide Medical Corp.

    K Number Device Name
    K993852 FIRST CHECK HOME DRUG TEST PANEL 4
    K994138 FIRST CHECK HOME DRUG TEST PANEL 3
    K993663 FIRST CHECK HOME DRUG TEST (THC)
    K994139 FIRST CHECK HOME DRUG TEST PANEL 2