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

    ENRICHED CULTURE MEDIUM

    K Number: K850735 · Decision Mar 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    50
    Applicant Total
    8
    Review Days
    24

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    Basic Information

    Device Name
    ENRICHED CULTURE MEDIUM
    K Number
    K850735
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Roseville Medical Laboratoriesu
    Date Received
    February 20, 1985
    Decision Date
    March 16, 1985
    Product Code
    KZI
    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
    KZI Culture Media, Enriched

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    Other Clearances by Roseville Medical Laboratoriesu

    K Number Device Name
    K850731 CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING
    K850738 SUPPLEMENT FOR CULTURE MEDIUM
    K850737 TRANSPORT CULTURE MEDIUM
    K850736 SELECTIVE CULTURE MEDIUM
    K850733 MULTIPURPOSE CULTURE MEDIUM
    K850732 CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI
    K850734 DIFFERENTIAL CULTURE MEDIUM