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

    PROSPEC T/GIARDIA RAPID ASSAY

    K Number: K911337 · Decision Sep 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    26
    Applicant Total
    10
    Review Days
    185

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    Basic Information

    Device Name
    PROSPEC T/GIARDIA RAPID ASSAY
    K Number
    K911337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Alexon, Inc.
    Date Received
    March 26, 1991
    Decision Date
    September 27, 1991
    Product Code
    MHI
    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
    MHI Giardia Spp.

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