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

    MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM

    K Number: K855205 · Decision Feb 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    284
    Applicant Total
    8
    Review Days
    37

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    Basic Information

    Device Name
    MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
    K Number
    K855205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hana Biologics, Inc.
    Date Received
    December 30, 1985
    Decision Date
    February 5, 1986
    Product Code
    JSI
    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
    JSI Culture Media, Selective And Differential

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    Other Clearances by Hana Biologics, Inc.

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