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

    RESPIRATORY SYNCYTIAL VIRUS

    K Number: K894623 · Decision Oct 16, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    22
    Applicant Total
    14
    Review Days
    88

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    Basic Information

    Device Name
    RESPIRATORY SYNCYTIAL VIRUS
    K Number
    K894623
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bion Ent., Ltd.
    Date Received
    July 20, 1989
    Decision Date
    October 16, 1989
    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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    Other Clearances by Bion Ent., Ltd.

    K Number Device Name
    K926066 BION MUMPS-G ANTIBODY TEST SYSTEM
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    K894622 VARICELLA ZOSTER VIRUS
    K894624 MUMPS VIRUS
    K894626 EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
    K891785 BION EBV-G (VCA) TEST SYSTEM
    K894625 CHLAMYDIA (LGV-1)
    K893240 BION EBV-M (VCA) TEST SYSTEM
    K890616 BION DIRECT IDENTIFICATION CONTROL SLIDE
    K881261 BION HSV1-G OR HSV2-G TEST SYSTEM
    Search all 14 clearances from Bion Ent., Ltd. →