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

    JBAIDS Q FEVER DETECTION KIT

    K Number: K103207 · Decision May 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    8
    Review Days
    200

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    Basic Information

    Device Name
    JBAIDS Q FEVER DETECTION KIT
    K Number
    K103207
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3500
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Idaho Technology, Inc.
    Date Received
    November 1, 2010
    Decision Date
    May 20, 2011
    Product Code
    OVF
    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
    OVF Assay, Direct, Nucleic Acid Amplification, Q Fever

    Other Clearances by Idaho Technology, Inc.

    K Number Device Name
    K120267 FILMARRAY RP PANEL
    K110764 FILMARRAY RP PANEL
    K103175 FILMARRAY RESPIRATORY PANEL (RP)
    K072631 JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
    K072547 JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
    K071188 MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
    K051713 JBAIDS ANTHRAC DETECTION SYSTEM