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

    STREP-KIT

    K Number: K850765 · Decision Apr 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    306
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    STREP-KIT
    K Number
    K850765
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Culture Kits, Inc.
    Date Received
    February 25, 1985
    Decision Date
    April 24, 1985
    Product Code
    JSJ
    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
    JSJ Culture Media, Selective And Non-Differential

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