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

    IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)

    K Number: K972861 · Decision Aug 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    66
    Applicant Total
    321
    Review Days
    15

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    Basic Information

    Device Name
    IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
    K Number
    K972861
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    August 4, 1997
    Decision Date
    August 19, 1997
    Product Code
    JJS
    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
    JJS Controls For Blood-Gases, (Assayed And Unassayed)

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