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

    SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA

    K Number: K945839 · Decision Mar 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    199
    Review Days
    97

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    Basic Information

    Device Name
    SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA
    K Number
    K945839
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3550
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sa Scientific, Inc.
    Date Received
    November 30, 1994
    Decision Date
    March 7, 1995
    Product Code
    GRL
    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
    GRL Antigens, All Groups, Salmonella Spp.

    Similar 510(k) Clearances

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    SALMONELLA & SHIGELLA GROUPING SERA

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