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

    VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)

    K Number: K120466 · Decision Nov 6, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    265

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    Basic Information

    Device Name
    VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
    K Number
    K120466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanosphere, Inc.
    Date Received
    February 15, 2012
    Decision Date
    November 6, 2012
    Product Code
    NTI
    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
    NTI Drug Metabolizing Enzyme Genotyping Systems

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    Other Clearances by Nanosphere, Inc.

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    K123197 VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
    K122514 VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
    DEN120014 VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
    K112424 VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
    K103209 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
    K093337 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
    K092957 VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
    Search all 16 clearances from Nanosphere, Inc. →