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

    HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

    K Number: K951241 · Decision Oct 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    50
    Review Days
    222

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    Basic Information

    Device Name
    HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
    K Number
    K951241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Radiometer America, Inc.
    Date Received
    February 27, 1995
    Decision Date
    October 7, 1995
    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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