BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MICROTECH BACTERIAL CONTROLS

    K Number: K822954 · Decision Nov 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    43

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    Basic Information

    Device Name
    MICROTECH BACTERIAL CONTROLS
    K Number
    K822954
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Universal Micro Reference Laboratory
    Date Received
    October 4, 1982
    Decision Date
    November 16, 1982
    Product Code
    JTR
    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
    JTR Kit, Quality Control For Culture Media

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