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

    E-VAC BLOOD CULTURE SYSTEM

    K Number: K802408 · Decision Oct 23, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    51
    Applicant Total
    6
    Review Days
    20

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    Basic Information

    Device Name
    E-VAC BLOOD CULTURE SYSTEM
    K Number
    K802408
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2350
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pfizer Pharmaceuticals
    Date Received
    October 3, 1980
    Decision Date
    October 23, 1980
    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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