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

    REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.

    K Number: K864862 · Decision Feb 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.
    K Number
    K864862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hf Scientific, Inc.
    Date Received
    December 11, 1986
    Decision Date
    February 20, 1987
    Product Code
    JGS
    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
    JGS Electrode, Ion Specific, Sodium

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