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

    ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES

    K Number: K982429 · Decision Aug 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    71
    Applicant Total
    4
    Review Days
    43

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    Basic Information

    Device Name
    ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
    K Number
    K982429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zymetx, Inc.
    Date Received
    July 13, 1998
    Decision Date
    August 25, 1998
    Product Code
    PSZ
    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
    PSZ Devices Detecting Influenza A, B, And C Virus Antigens

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    Other Clearances by Zymetx, Inc.

    K Number Device Name
    K984596 VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
    K971494 VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
    K950838 VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES