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

    JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124

    K Number: K072547 · Decision Dec 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    100

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    Basic Information

    Device Name
    JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
    K Number
    K072547
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3280
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Idaho Technology, Inc.
    Date Received
    September 10, 2007
    Decision Date
    December 19, 2007
    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

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    FDA 510(k)
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