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

    NEOTHROMITIN(R)

    K Number: K924395 · Decision Dec 1, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    145
    Review Days
    92

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    Basic Information

    Device Name
    NEOTHROMITIN(R)
    K Number
    K924395
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3500
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    August 31, 1992
    Decision Date
    December 1, 1992
    Product Code
    GPO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GPO Antigen, Cf, Typhus Fever Group

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