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

    HSV-2 ANTIGEN CONTROL SLIDES

    K Number: K971101 · Decision Jul 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    6
    Review Days
    97

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    Basic Information

    Device Name
    HSV-2 ANTIGEN CONTROL SLIDES
    K Number
    K971101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Viral Antigens, Inc.
    Date Received
    March 26, 1997
    Decision Date
    July 1, 1997
    Product Code
    GQN
    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
    GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

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