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

    TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE

    K Number: K851148 · Decision Apr 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    5
    Review Days
    39

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    Basic Information

    Device Name
    TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE
    K Number
    K851148
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Euro-Diagnostics BV
    Date Received
    March 21, 1985
    Decision Date
    April 29, 1985
    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 Euro-Diagnostics BV

    K Number Device Name
    K851332 BLHI LUTEINIZING HORMONE
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    K843930 IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
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