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

    HSV-1 ELISA IGG, MODEL EL0910G

    K Number: K993754 · Decision Feb 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    7
    Review Days
    96

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    Basic Information

    Device Name
    HSV-1 ELISA IGG, MODEL EL0910G
    K Number
    K993754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mrl Diagnostics
    Date Received
    November 5, 1999
    Decision Date
    February 9, 2000
    Product Code
    MXJ
    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
    MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

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    Other Clearances by Mrl Diagnostics

    K Number Device Name
    K000238 HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
    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
    K931520 EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY