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

    THYRODOT-4, THYRODOT-SH

    K Number: K771377 · Decision Sep 2, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    2
    Review Days
    39

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    Basic Information

    Device Name
    THYRODOT-4, THYRODOT-SH
    K Number
    K771377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medcom Diagnostics, Inc.
    Date Received
    July 25, 1977
    Decision Date
    September 2, 1977
    Product Code
    JLW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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    Other Clearances by Medcom Diagnostics, Inc.

    K Number Device Name
    K772064 THYRODOT-4 ANTISERA LYOPHOLIZED