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

    STREPTOCOCCUS APP. SEROLOGICAL REAGENTS

    K Number: K122019 · Decision Sep 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    38
    Review Days
    65

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    Basic Information

    Device Name
    STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
    K Number
    K122019
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meridian Bioscience, Inc.
    Date Received
    July 10, 2012
    Decision Date
    September 13, 2012
    Product Code
    OYZ
    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
    OYZ Group A Streptococcus Nucleic Acid Amplification Assay System

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