BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

    K Number: K003204 · Decision Nov 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    15
    Applicant Total
    5
    Review Days
    25

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    Basic Information

    Device Name
    BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
    K Number
    K003204
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intracel Corp.
    Date Received
    October 13, 2000
    Decision Date
    November 7, 2000
    Product Code
    GNW
    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
    GNW Antisera, Cf, Influenza Virus A, B, C

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