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

    DIAGNOSTIC REAGENT PET-RPLA

    K Number: K855235 · Decision Nov 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    17
    Applicant Total
    93
    Review Days
    308

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    Basic Information

    Device Name
    DIAGNOSTIC REAGENT PET-RPLA
    K Number
    K855235
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    December 31, 1985
    Decision Date
    November 4, 1986
    Product Code
    JSP
    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
    JSP Kit, Anaerobic Identification

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