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

    MICROTRAK HSV CULTURE IDENTIFICATION TEST

    K Number: K880436 · Decision Feb 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    448
    Review Days
    16

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    Basic Information

    Device Name
    MICROTRAK HSV CULTURE IDENTIFICATION TEST
    K Number
    K880436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Syva Co.
    Date Received
    February 2, 1988
    Decision Date
    February 18, 1988
    Product Code
    GQN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

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    K993980 SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
    K993987 SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
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