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

    MYCOTRIUM-GU

    K Number: K822736 · Decision Dec 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    284
    Applicant Total
    8
    Review Days
    85

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    Basic Information

    Device Name
    MYCOTRIUM-GU
    K Number
    K822736
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Hana Biologics, Inc.
    Date Received
    September 9, 1982
    Decision Date
    December 3, 1982
    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.

    K Number Device Name
    K883682 CHANG MEDIUM (ADDITIONAL INDICATIONS)
    K855205 MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
    K834616 AMNIO STAT-FLM AGGLUTINATION TEST
    K833933 ACE COLOR TEST
    K822737 MYCOTRIUM-RS
    K822150 AMNISTAT-FLM
    K812820 CHANG MEDIUM