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

    API 50 CHB (CULTURE MEDIA)

    K Number: K854732 · Decision Mar 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    99

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    Basic Information

    Device Name
    API 50 CHB (CULTURE MEDIA)
    K Number
    K854732
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Dms Products, Inc.
    Date Received
    November 25, 1985
    Decision Date
    March 4, 1986
    Product Code
    JST
    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
    JST Kit, Fastidious Organisms

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    Other Clearances by Dms Products, Inc.

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    K854733 API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)