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

    JBAIDS TULAREMIA DETECTION KIT

    K Number: K131936 · Decision Jul 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    34

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    Basic Information

    Device Name
    JBAIDS TULAREMIA DETECTION KIT
    K Number
    K131936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3280
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Diagnostics, Inc.
    Date Received
    June 27, 2013
    Decision Date
    July 31, 2013
    Product Code
    OEH
    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
    OEH Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

    Similar 510(k) Clearances

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

    JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124

    FDA 510(k)
    FDA Class 2 ·Microbiology
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    Other Clearances by Biofire Diagnostics, Inc.

    K Number Device Name
    K131930 JBAIDS ANTHRAX DETECTION KIT
    K131729 JBAIDS PLAGUE DETECTION KIT
    K130914 FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
    K123620 FILMARRAY RESPIRATORY PANEL (RP)