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

    VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

    K Number: DEN120014 · Decision Jun 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    16
    Review Days
    11

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
    K Number
    DEN120014
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.3365
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Nanosphere, Inc.
    Date Received
    June 15, 2012
    Decision Date
    June 26, 2012
    Product Code
    PAM
    Advisory Committee
    Microbiology
    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
    PAM Gram-Positive Bacteria And Their Resistance Markers

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PAM), ordered by most recent decision date.

    LIAISON PLEX Gram-Positive Blood Culture Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    iC-GPC Assay TM for use on the iC-SystemTM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Great Basin Staph ID/R Blood Culture Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Nanosphere, Inc.

    K Number Device Name
    K143653 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
    K140083 VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
    K132843 VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
    K123197 VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
    K120466 VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
    K122514 VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
    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. →