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

    AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II

    K Number: K042975 · Decision Dec 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    14
    Review Days
    62

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    Basic Information

    Device Name
    AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II
    K Number
    K042975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ameditech, Inc.
    Date Received
    October 28, 2004
    Decision Date
    December 29, 2004
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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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
    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
    K012582 AMEDITECH IMMUTEST DRUG SCREEN PCP
    Search all 14 clearances from Ameditech, Inc. →