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

    STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

    K Number: K974798 · Decision Mar 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    8
    Review Days
    88

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    Basic Information

    Device Name
    STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
    K Number
    K974798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Environmental Test Systems, Inc.
    Date Received
    December 22, 1997
    Decision Date
    March 20, 1998
    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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