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

    BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000

    K Number: K861301 · Decision Apr 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    12
    Review Days
    14

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    Basic Information

    Device Name
    BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000
    K Number
    K861301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Troy Biologicals, Inc.
    Date Received
    April 7, 1986
    Decision Date
    April 21, 1986
    Product Code
    JTZ
    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
    JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

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