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

    VIROGEN CMV ANTIBODY TEST

    K Number: K875101 · Decision Mar 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    12
    Review Days
    82

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    Basic Information

    Device Name
    VIROGEN CMV ANTIBODY TEST
    K Number
    K875101
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Wampole Laboratories
    Date Received
    December 10, 1987
    Decision Date
    March 1, 1988
    Product Code
    LQO
    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
    LQO Dna-Reagents, Campylobacter Spp.

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