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

    SUPPLEMENT FOR CULTURE MEDIUM

    K Number: K850738 · Decision Mar 20, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    69
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    SUPPLEMENT FOR CULTURE MEDIUM
    K Number
    K850738
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2450
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Roseville Medical Laboratoriesu
    Date Received
    February 20, 1985
    Decision Date
    March 20, 1985
    Product Code
    JSK
    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
    JSK Supplement, Culture Media

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    Other Clearances by Roseville Medical Laboratoriesu

    K Number Device Name
    K850731 CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING
    K850737 TRANSPORT CULTURE MEDIUM
    K850736 SELECTIVE CULTURE MEDIUM
    K850733 MULTIPURPOSE CULTURE MEDIUM
    K850732 CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI
    K850734 DIFFERENTIAL CULTURE MEDIUM
    K850735 ENRICHED CULTURE MEDIUM