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

    SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)

    K Number: K911629 · Decision Jun 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    27
    Review Days
    77

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    Basic Information

    Device Name
    SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
    K Number
    K911629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Serim Research Corp.
    Date Received
    April 11, 1991
    Decision Date
    June 27, 1991
    Product Code
    LIF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIF Dialyzer Reprocessing System

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