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

    RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL

    K Number: K872701 · Decision Sep 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    22
    Applicant Total
    9
    Review Days
    73

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    Basic Information

    Device Name
    RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL
    K Number
    K872701
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Sita, Inc.
    Date Received
    July 7, 1987
    Decision Date
    September 18, 1987
    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 Sita, Inc.

    K Number Device Name
    K872700 YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
    K872698 ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN
    K872697 PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN
    K872694 YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN
    K872693 INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN
    K872695 PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN
    K872699 MUMPS CF ANTIGEN AND CONTROL ANTIGEN
    K872696 PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN