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

    EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY

    K Number: K931520 · Decision Apr 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    7
    Review Days
    396

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    Basic Information

    Device Name
    EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY
    K Number
    K931520
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mrl Diagnostics
    Date Received
    March 26, 1993
    Decision Date
    April 26, 1994
    Product Code
    LJN
    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
    LJN Antibody Igm, If, Epstein-Barr Virus

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    Other Clearances by Mrl Diagnostics

    K Number Device Name
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    K993754 HSV-1 ELISA IGG, MODEL EL0910G
    K993724 HSV-2 ELISA IGG, MODEL EL0920G
    K971006 LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
    K971007 LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
    K946353 EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY