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

    BACTIGEN SALMONELLA-SHIGELLA TEST

    K Number: K870813 · Decision Apr 22, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    68
    Applicant Total
    68
    Review Days
    50

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    Basic Information

    Device Name
    BACTIGEN SALMONELLA-SHIGELLA TEST
    K Number
    K870813
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3550
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Armkel, LLC
    Date Received
    March 3, 1987
    Decision Date
    April 22, 1987
    Product Code
    GRM
    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
    GRM Antisera, All Groups, Salmonella Spp.

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