BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GENTAMICIN FLEX REAGENT CARTRIDGE

    K Number: K962819 · Decision Sep 13, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    36
    Applicant Total
    30
    Review Days
    56

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    Basic Information

    Device Name
    GENTAMICIN FLEX REAGENT CARTRIDGE
    K Number
    K962819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3450
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dade Intl., Inc.
    Date Received
    July 19, 1996
    Decision Date
    September 13, 1996
    Product Code
    LCD
    Advisory Committee
    Clinical Toxicology
    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
    LCD Enzyme Immunoassay, Gentamicin

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    Other Clearances by Dade Intl., Inc.

    K Number Device Name
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    K973974 DADE TRU-LIQUID CARDIAC CONTROL
    K973668 CARDIAC TROPONIN-I (TROP) CALIBRATOR
    K972524 DRIED GRAM-POSITIVE MIC/COMBO PANELS
    K972782 DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
    K972287 DADE TRU-LIQUID BILIRUBIN CONTROL
    K964660 PARAMAX CHOLESTEROL REAGENT
    K970676 DRIED GRAM-NEGATIVE MIC/COMBO PANELS
    K964715 PARAMAX SALICYLATE REAGENT
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