BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REAL-TIME PCR INTERNAL CONTROL 2B SET

    K Number: K083430 · Decision Jan 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    REAL-TIME PCR INTERNAL CONTROL 2B SET
    K Number
    K083430
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nanogen, Inc.
    Date Received
    November 19, 2008
    Decision Date
    January 15, 2009
    Product Code
    OLD
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLD Internal Polymerase Chain Reaction Control, Not Assay Specific

    Other Clearances by Nanogen, Inc.

    K Number Device Name
    K051596 STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204