BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HAEMOPHILUS TEST MEDIUM (BROTH)

    K Number: K894848 · Decision Sep 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    37

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    Basic Information

    Device Name
    HAEMOPHILUS TEST MEDIUM (BROTH)
    K Number
    K894848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Regional Media Laboratories
    Date Received
    July 31, 1989
    Decision Date
    September 6, 1989
    Product Code
    JSO
    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
    JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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    Other Clearances by Regional Media Laboratories

    K Number Device Name
    K792674 CAMPY BLOOD AGAR