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

    VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES

    K Number: K950838 · Decision Jun 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    4
    Review Days
    479

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    Basic Information

    Device Name
    VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
    K Number
    K950838
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zymetx, Inc.
    Date Received
    February 24, 1995
    Decision Date
    June 17, 1996
    Product Code
    GNT
    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
    GNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GNT), ordered by most recent decision date.

    QTEST INFLUENZA A

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    DIRECTIGEN FLU A

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    INFLUENZA HA ANTIGEN A/USSR

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    FDA Class 1 ·Microbiology

    INFLUENZA HA ANTIGEN

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    FDA Class 1 ·Microbiology
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    Other Clearances by Zymetx, Inc.

    K Number Device Name
    K984596 VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
    K982429 ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
    K971494 VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES