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

    UNKNOWN

    K Number: K934774 · Decision Apr 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    55
    Applicant Total
    8
    Review Days
    197

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    Basic Information

    Device Name
    UNKNOWN
    K Number
    K934774
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Granbio, Inc.
    Date Received
    October 5, 1993
    Decision Date
    April 20, 1994
    Product Code
    LSE
    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
    LSE Epstein-Barr Virus, Other

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