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

    EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST

    K Number: K933251 · Decision Jun 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    5
    Review Days
    346

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    Basic Information

    Device Name
    EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
    K Number
    K933251
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Virion (U.S.), Inc.
    Date Received
    July 2, 1993
    Decision Date
    June 13, 1994
    Product Code
    MCD
    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
    MCD Antigen, Ebv, Capsid

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    Other Clearances by Virion (U.S.), Inc.

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