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

    ACID FAST BACILLI HISTOLOGY CONTROL SLIDES

    K Number: K881106 · Decision Apr 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    26
    Applicant Total
    164
    Review Days
    37

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    Basic Information

    Device Name
    ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
    K Number
    K881106
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    March 15, 1988
    Decision Date
    April 21, 1988
    Product Code
    LJG
    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
    LJG Quality Control Slides

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