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

    MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR

    K Number: K900705 · Decision Apr 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    26
    Applicant Total
    28
    Review Days
    59

    Basic Information

    Device Name
    MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
    K Number
    K900705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    INNOTRON OF OREGON, INC.
    Date Received
    February 12, 1990
    Decision Date
    April 12, 1990
    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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