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

    CMV ANTIGEN CONTROL SLIDES

    K Number: K964875 · Decision Mar 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    103

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    Basic Information

    Device Name
    CMV ANTIGEN CONTROL SLIDES
    K Number
    K964875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Viral Antigens, Inc.
    Date Received
    December 5, 1996
    Decision Date
    March 18, 1997
    Product Code
    GQH
    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
    GQH Antigen, Cf (Including Cf Control), Cytomegalovirus

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    Other Clearances by Viral Antigens, Inc.

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