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

    FORMASURE TEST REAGENT

    K Number: K905217 · Decision Apr 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    140

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    Basic Information

    Device Name
    FORMASURE TEST REAGENT
    K Number
    K905217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Di-Chem, Inc.
    Date Received
    November 20, 1990
    Decision Date
    April 9, 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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