BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    THYROGLOBULIN EIA TEST KIT

    K Number: K951362 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    14
    Review Days
    241

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    Basic Information

    Device Name
    THYROGLOBULIN EIA TEST KIT
    K Number
    K951362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Immunoprobe, Inc.
    Date Received
    March 24, 1995
    Decision Date
    November 20, 1995
    Product Code
    JNL
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JNL Immunochemical, Thyroglobulin Autoantibody

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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
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    K961764 PR-3 ELISA TEST SYSTEM
    K951549 EBNA IGG EIA 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
    K951363 CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
    Search all 14 clearances from Immunoprobe, Inc. →