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

    RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION

    K Number: K884192 · Decision Nov 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    22
    Applicant Total
    72
    Review Days
    47

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    Basic Information

    Device Name
    RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
    K Number
    K884192
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    October 6, 1988
    Decision Date
    November 22, 1988
    Product Code
    LKT
    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
    LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa

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