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

    BRAIN HEART INFUSION BROTH

    K Number: K791194 · Decision Jul 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    51
    Applicant Total
    93
    Review Days
    22

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    Basic Information

    Device Name
    BRAIN HEART INFUSION BROTH
    K Number
    K791194
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2350
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Isle Media and Sterile Products, Inc.
    Date Received
    June 25, 1979
    Decision Date
    July 17, 1979
    Product Code
    JSC
    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
    JSC Culture Media, General Nutrient Broth

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