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

    QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

    K Number: K052826 · Decision Dec 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    26
    Applicant Total
    28
    Review Days
    79

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    Basic Information

    Device Name
    QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
    K Number
    K052826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seradyn, Inc.
    Date Received
    October 5, 2005
    Decision Date
    December 23, 2005
    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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    K042307 ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
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