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

    ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

    K Number: K971834 · Decision Jul 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    21
    Review Days
    45

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    Basic Information

    Device Name
    ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
    K Number
    K971834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Monobind
    Date Received
    May 19, 1997
    Decision Date
    July 3, 1997
    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 Monobind

    K Number Device Name
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    K020548 FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
    K980088 T-UPTAKE MICROPLATE EIA
    K972720 FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
    K971835 ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
    K971780 THYROTROPIN(TSH) ELISA
    K971921 PROLACTIN (PRL) HORMONE MICROPLATE ELISA
    K971779 TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
    K971709 TOTAL THROXINE MICROPLATE EIA(225-300)
    K926345 TRIODOTHYRONINE (TC) COATED TUBE RIA
    Search all 21 clearances from Monobind →