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

    ABBOTT STREP A CONTROLS

    K Number: K972182 · Decision Aug 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    2
    Applicant Total
    28
    Review Days
    76

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    Basic Information

    Device Name
    ABBOTT STREP A CONTROLS
    K Number
    K972182
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Diagnostics
    Date Received
    May 29, 1997
    Decision Date
    August 13, 1997
    Product Code
    MJZ
    Advisory Committee
    Clinical Chemistry
    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
    MJZ Kit, Direct Antigen, Positive Control

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