BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    CARIESCREEN - SM

    K Number: K852987 · Decision Aug 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    306
    Applicant Total
    2
    Review Days
    35

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    Basic Information

    Device Name
    CARIESCREEN - SM
    K Number
    K852987
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pharma-Medica of Scandinavia, Ltd.
    Date Received
    July 15, 1985
    Decision Date
    August 19, 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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