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

    I-STAT CONTROL LEVELS 1,2,3

    K Number: K934641 · Decision Dec 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    14
    Review Days
    79

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    Basic Information

    Device Name
    I-STAT CONTROL LEVELS 1,2,3
    K Number
    K934641
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I-Stat Corp.
    Date Received
    September 21, 1993
    Decision Date
    December 9, 1993
    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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