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

    10B

    K Number: K833968 · Decision Dec 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    12
    Applicant Total
    137
    Review Days
    44

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    Basic Information

    Device Name
    10B
    K Number
    K833968
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Remel Co.
    Date Received
    November 16, 1983
    Decision Date
    December 30, 1983
    Product Code
    JSN
    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
    JSN Culture Media, Propagating Transport

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