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

    AMNISTAT-FLM

    K Number: K822150 · Decision Oct 21, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    8
    Review Days
    91

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    Basic Information

    Device Name
    AMNISTAT-FLM
    K Number
    K822150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1455
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hana Biologics, Inc.
    Date Received
    July 22, 1982
    Decision Date
    October 21, 1982
    Product Code
    JHG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    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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