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

    HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

    K Number: K912778 · Decision Feb 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    3
    Review Days
    239

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    Basic Information

    Device Name
    HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
    K Number
    K912778
    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 24, 1991
    Decision Date
    February 18, 1992
    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
    K912846 JUSTONE(TM)
    K912613 GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)