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

    DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET

    K Number: K881773 · Decision Jun 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    38
    Review Days
    45

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    Basic Information

    Device Name
    DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
    K Number
    K881773
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Casco Standards
    Date Received
    April 26, 1988
    Decision Date
    June 10, 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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