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

    NICHOLS ADVANTAGE THYROGLOB

    K Number: K002888 · Decision Oct 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    12
    Applicant Total
    68
    Review Days
    35

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    Basic Information

    Device Name
    NICHOLS ADVANTAGE THYROGLOB
    K Number
    K002888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nichols Institute Diagnostics
    Date Received
    September 15, 2000
    Decision Date
    October 20, 2000
    Product Code
    MSW
    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
    MSW System, Test, Thyroglobulin

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    Other Clearances by Nichols Institute Diagnostics

    K Number Device Name
    K050784 NICHOLS ADVANTAGE ALDOSTERONE ASSAY
    K042676 NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
    K042689 NICHOLS ADVANTAGE CORTISOL
    K040813 NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
    K033727 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
    K033302 NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
    K032188 NICHOLS ADVANTAGE ALDOSTERONE ASSAY
    K022356 NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
    K022472 PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
    K013992 NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
    Search all 68 clearances from Nichols Institute Diagnostics →