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

    PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M

    K Number: K073381 · Decision Aug 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    22
    Applicant Total
    14
    Review Days
    245

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    Basic Information

    Device Name
    PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
    K Number
    K073381
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Focus Diagnostics, Inc.
    Date Received
    December 3, 2007
    Decision Date
    August 4, 2008
    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 Focus Diagnostics, Inc.

    K Number Device Name
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    K120986 STRATIFY JCV DXSELECT
    K120413 SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
    K113433 SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
    DEN120008 STRATIFY JCV(TM) ANTIBODY
    K102170 SIMPLEXA FLU A/B & RSV
    K102314 3M INTEGRATED CYCLER (110V) & (220V)
    K100148 SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
    K073382 PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G
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