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

    CARIESCREEN LB

    K Number: K871264 · Decision May 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    306
    Applicant Total
    1
    Review Days
    37

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    Basic Information

    Device Name
    CARIESCREEN LB
    K Number
    K871264
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Apo Diagnostics, Inc.
    Date Received
    March 31, 1987
    Decision Date
    May 7, 1987
    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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