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

    Fungitell STAT

    K Number: K191167 · Decision Jul 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    77

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    Basic Information

    Device Name
    Fungitell STAT
    K Number
    K191167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3050
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Associates of Cape Cod, Inc.
    Date Received
    May 1, 2019
    Decision Date
    July 17, 2019
    Product Code
    NQZ
    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
    NQZ Antigen, Invasive Fungal Pathogens

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NQZ), ordered by most recent decision date.

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    Other Clearances by Associates of Cape Cod, Inc.

    K Number Device Name
    DEN040003 GLUCATELL