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

    THYROTROPIN(TSH) ELISA

    K Number: K971780 · Decision Jun 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    240
    Applicant Total
    21
    Review Days
    41

    Basic Information

    Device Name
    THYROTROPIN(TSH) ELISA
    K Number
    K971780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MONOBIND
    Date Received
    May 14, 1997
    Decision Date
    June 24, 1997
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JLW), ordered by most recent decision date.

    Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur® TSH3-Ultra II (TSH3ULII)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys TSH

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    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
    K971921 PROLACTIN (PRL) HORMONE MICROPLATE ELISA
    K971709 TOTAL THROXINE MICROPLATE EIA(225-300)
    K971779 TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
    K926345 TRIODOTHYRONINE (TC) COATED TUBE RIA
    Search all 21 clearances from MONOBIND →