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

    AUTOMATES COMA COCAINE METABOLITE ASSAY

    K Number: K921834 · Decision Jun 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    5
    Review Days
    60

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    Basic Information

    Device Name
    AUTOMATES COMA COCAINE METABOLITE ASSAY
    K Number
    K921834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Serex, Inc.
    Date Received
    April 16, 1992
    Decision Date
    June 15, 1992
    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 Serex, Inc.

    K Number Device Name
    K923314 AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY
    K901333 BETA-2 MICROGLOBULIN EIA
    K895043 COMA COCAINE METABOLITE ASSAY (EIA)
    K890694 BETA-2 MICROGLOBULIN EIA