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

    GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)

    K Number: K912613 · Decision Aug 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    433
    Applicant Total
    3
    Review Days
    71

    Basic Information

    Device Name
    GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
    K Number
    K912613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    SENSITITRE MICROBIOLOGY A DIV. OF RADIOMETER
    Date Received
    June 12, 1991
    Decision Date
    August 22, 1991
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

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    Other Clearances by SENSITITRE MICROBIOLOGY A DIV. OF RADIOMETER

    K Number Device Name
    K912778 HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
    K912846 JUSTONE(TM)