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

    THYROXINE (T4) COATED TUBE RIA

    K Number: K921935 · Decision Jul 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    21
    Review Days
    74

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    Basic Information

    Device Name
    THYROXINE (T4) COATED TUBE RIA
    K Number
    K921935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Monobind
    Date Received
    April 24, 1992
    Decision Date
    July 7, 1992
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

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    Other Clearances by Monobind

    K Number Device Name
    K030860 ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
    K020548 FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
    K980088 T-UPTAKE MICROPLATE EIA
    K972720 FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
    K971834 ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
    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)
    Search all 21 clearances from Monobind →