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

    FPR AMIKACIN CALIBRATOR KIT

    K Number: K894518 · Decision Sep 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    16
    Review Days
    70

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    Basic Information

    Device Name
    FPR AMIKACIN CALIBRATOR KIT
    K Number
    K894518
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2250
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Colony Laboratories, Inc.
    Date Received
    July 20, 1989
    Decision Date
    September 28, 1989
    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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    Other Clearances by Colony Laboratories, Inc.

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    K894527 FPR PHENYTOIN KIT
    K894528 FPR PHENYTOIN CALIBRATOR KIT
    K894522 FPR DIGOXIN CALIBRATOR KIT
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