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

    STRATUS QUINIDINE FLUOROMETRIC ENZYME

    K Number: K843237 · Decision Sep 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    26
    Applicant Total
    149
    Review Days
    21

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    Basic Information

    Device Name
    STRATUS QUINIDINE FLUOROMETRIC ENZYME
    K Number
    K843237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    August 22, 1984
    Decision Date
    September 12, 1984
    Product Code
    LBZ
    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
    LBZ Enzyme Immunoassay, Quinidine

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    K871972 STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
    K871977 DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
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