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

    AMEDITECH IMMUTEST DRUG SCREEN THC

    K Number: K011813 · Decision Oct 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    14
    Review Days
    133

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    Basic Information

    Device Name
    AMEDITECH IMMUTEST DRUG SCREEN THC
    K Number
    K011813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ameditech, Inc.
    Date Received
    June 11, 2001
    Decision Date
    October 22, 2001
    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 Ameditech, Inc.

    K Number Device Name
    K113501 AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
    K113046 AMEDITECH IMMUTEST MILTI-DRUG SCREEN
    K063015 AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
    K053175 AMEDITECH DRUGSMARTCUP
    K050186 AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III
    K042975 AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
    K040092 AMEDITECH IMMU TEST DRUG SCREEN PANEL
    K023126 AMEDITECH IMMUTEST HCG PREGANCY TEST
    K012483 AMEDITECH IMMUTEST DRUG SCREEN OPIATES
    K012484 AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
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