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

    EBNA ANTIBODY

    K Number: K875170 · Decision May 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    33
    Review Days
    158

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    Basic Information

    Device Name
    EBNA ANTIBODY
    K Number
    K875170
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hillcrest Biologicals
    Date Received
    December 17, 1987
    Decision Date
    May 23, 1988
    Product Code
    LLM
    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
    LLM Test, Antigen, Nuclear, Epstein-Barr Virus

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    Other Clearances by Hillcrest Biologicals

    K Number Device Name
    K913618 ARBOVIRUS IGM IFA TEST
    K913617 ARBOVIRUS IGG IFA TEST
    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)
    K884591 EBV-VCA ANTIBODY (IGG)
    K883487 LYME DISEASE IFA (IGG)
    Search all 33 clearances from Hillcrest Biologicals →