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

    AMNIOSTAT-FLM-PG

    K Number: K061549 · Decision Oct 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    40
    Review Days
    135

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    Basic Information

    Device Name
    AMNIOSTAT-FLM-PG
    K Number
    K061549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1455
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Irvine Scientific Sales Co., Inc.
    Date Received
    June 5, 2006
    Decision Date
    October 18, 2006
    Product Code
    JHG
    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
    JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio

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