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

    FIRST CHECK HOME DRUG TEST PANEL 3

    K Number: K994138 · Decision Jun 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    5
    Review Days
    199

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    Basic Information

    Device Name
    FIRST CHECK HOME DRUG TEST PANEL 3
    K Number
    K994138
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Worldwide Medical Corp.
    Date Received
    December 7, 1999
    Decision Date
    June 23, 2000
    Product Code
    LDJ
    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
    LDJ Enzyme Immunoassay, Cannabinoids

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    Other Clearances by Worldwide Medical Corp.

    K Number Device Name
    K020869 FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
    K993852 FIRST CHECK HOME DRUG TEST PANEL 4
    K993663 FIRST CHECK HOME DRUG TEST (THC)
    K994139 FIRST CHECK HOME DRUG TEST PANEL 2