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

    IL TEST DAT CAL/CONTROL SET D/E

    K Number: K920419 · Decision Mar 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    321
    Review Days
    40

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    Basic Information

    Device Name
    IL TEST DAT CAL/CONTROL SET D/E
    K Number
    K920419
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2250
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    January 31, 1992
    Decision Date
    March 11, 1992
    Product Code
    DLG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DLG Coating, Liquid, Glc

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