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

    MICROSTAT 2

    K Number: K984485 · Decision Jan 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    27

    Basic Information

    Device Name
    MICROSTAT 2
    K Number
    K984485
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6890
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    CHEMLINK LABORATORIES LLC.
    Date Received
    December 17, 1998
    Decision Date
    January 13, 1999
    Product Code
    LRJ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRJ Disinfectant, Medical Devices

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