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

    AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1

    K Number: K081767 · Decision Jan 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
    K Number
    K081767
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1550
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amnisure International, LLC
    Date Received
    June 20, 2008
    Decision Date
    January 9, 2009
    Product Code
    NQM
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NQM Immunoassay For Detection Of Amniotic Fluid Protein(S).

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