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

    EBV-VCA ANTIBODY (IGG)

    K Number: K884591 · Decision Jan 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    19
    Applicant Total
    33
    Review Days
    82

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    Basic Information

    Device Name
    EBV-VCA ANTIBODY (IGG)
    K Number
    K884591
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hillcrest Biologicals
    Date Received
    November 3, 1988
    Decision Date
    January 24, 1989
    Product Code
    GNP
    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
    GNP Antiserum, Cf, Epstein-Barr Virus

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    Other Clearances by Hillcrest Biologicals

    K Number Device Name
    K913618 ARBOVIRUS IGM IFA TEST
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    K913906 Q FEVER IGG IFA TEST
    K922374 Q FEVER IGM IFA TEST
    K900206 LYME DISEASE IGM ELISA
    K896594 EBV VCA ANTIBODY (IGM)
    K884829 EBV EARLY ANTIGEN (R+D)
    K883767 LYME DISEASE IFA (IGM)
    K883487 LYME DISEASE IFA (IGG)
    K875170 EBNA ANTIBODY
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