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

    VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES

    K Number: K971494 · Decision Sep 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    4
    Review Days
    139

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
    K Number
    K971494
    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
    April 24, 1997
    Decision Date
    September 10, 1997
    Product Code
    GNX
    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
    GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

    Similar 510(k) Clearances

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

    ALERE BINAXNOW INFLUENZA A & B CARD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SAS FLUALERT A & B, SAS INFLUENZA A TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    REMEL XPECT FLU A&B

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SOFIA INFLUENZA A+B FIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUICK VUE INFLUENZA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QUICKVUE INFLUENZA A+B

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    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
    K950838 VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES