BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    PROTECT T.M.

    K Number: K871121 · Decision Apr 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    11
    Applicant Total
    27
    Review Days
    26

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    Basic Information

    Device Name
    PROTECT T.M.
    K Number
    K871121
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pro-Lab, Inc.
    Date Received
    March 19, 1987
    Decision Date
    April 14, 1987
    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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