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

    EBNA IGG EIA TEST SYSTEM

    K Number: K951549 · Decision Apr 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    14
    Review Days
    391

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    Basic Information

    Device Name
    EBNA IGG EIA TEST SYSTEM
    K Number
    K951549
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunoprobe, Inc.
    Date Received
    April 4, 1995
    Decision Date
    April 29, 1996
    Product Code
    LLM
    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
    LLM Test, Antigen, Nuclear, Epstein-Barr Virus

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    Other Clearances by Immunoprobe, Inc.

    K Number Device Name
    K972406 ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
    K971393 MYCOPLASMA IGG ELISA TEST SYSTEM
    K961765 MPO ELISA TEST SYSTEM
    K961764 PR-3 ELISA TEST SYSTEM
    K952522 CARDIOLIPIN IGA EIA TEST SYSTEM
    K952523 CARDIOLIPIN IGG EIA TEST KIT
    K952521 CARDIOLIPIN IGM EIA TEST SYSTEM
    K951364 MICROSOMAL EIA TEST KIT
    K951362 THYROGLOBULIN EIA TEST KIT
    K951363 CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
    Search all 14 clearances from Immunoprobe, Inc. →