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

    MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY

    K Number: K011162 · Decision May 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    19
    Review Days
    16

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    Basic Information

    Device Name
    MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
    K Number
    K011162
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syva Co., Dade Behring, Inc.
    Date Received
    April 16, 2001
    Decision Date
    May 2, 2001
    Product Code
    DIO
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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    Other Clearances by Syva Co., Dade Behring, Inc.

    K Number Device Name
    K011920 EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
    K011620 EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
    K011605 EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
    K011300 EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
    K011306 EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
    K011161 MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
    K011289 EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
    K011163 MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
    K011166 MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
    K011164 MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
    Search all 19 clearances from Syva Co., Dade Behring, Inc. →