BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PROTEIN BASE ISE CONTROL

    K Number: K880710 · Decision Mar 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    49
    Review Days
    31

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    Basic Information

    Device Name
    PROTEIN BASE ISE CONTROL
    K Number
    K880710
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bionostics, Inc.
    Date Received
    February 22, 1988
    Decision Date
    March 24, 1988
    Product Code
    JJR
    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
    JJR Electrolyte Controls (Assayed And Unassayed)

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