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

    SIMPLEXA HSV 1&2 DIRECT

    K Number: DEN130049 · Decision Mar 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    116

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    Basic Information

    Device Name
    SIMPLEXA HSV 1&2 DIRECT
    K Number
    DEN130049
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3307
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Focus Diagnostics
    Date Received
    November 25, 2013
    Decision Date
    March 21, 2014
    Product Code
    PGH
    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
    PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

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    Other Clearances by Focus Diagnostics

    K Number Device Name
    K150962 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
    K142365 Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
    K141458 SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK