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

    COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS

    K Number: K941440 · Decision Jul 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    26
    Applicant Total
    296
    Review Days
    104

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    Basic Information

    Device Name
    COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
    K Number
    K941440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    March 24, 1994
    Decision Date
    July 6, 1994
    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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