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

    BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG

    K Number: K983841 · Decision Jun 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    222

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    Basic Information

    Device Name
    BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG
    K Number
    K983841
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotest Diagnostics Corp.
    Date Received
    October 30, 1998
    Decision Date
    June 9, 1999
    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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    Other Clearances by Biotest Diagnostics Corp.

    K Number Device Name
    K991650 CMV BRITE TURBO KIT
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    K951550 CMV BRITE ANTIGENEMIA TEST KIT