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

    EMIT AED ASSAYS 3500 COMPUTER DIRECTED

    K Number: K790255 · Decision Mar 2, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    55
    Applicant Total
    448
    Review Days
    24

    Basic Information

    Device Name
    EMIT AED ASSAYS 3500 COMPUTER DIRECTED
    K Number
    K790255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3645
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    SYVA CO.
    Date Received
    February 6, 1979
    Decision Date
    March 2, 1979
    Product Code
    KLT
    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
    KLT Enzyme Immunoassay, Carbamazepine

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    Other Clearances by SYVA CO.

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    K012257 EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
    K011947 EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
    K011528 EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
    K011347 EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
    K993980 SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
    K993981 SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
    K993029 ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
    K993031 ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
    K993988 SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
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