LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990993
    Device Name
    BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-06-22

    (90 days)

    Product Code
    JLW
    Regulation Number
    862.1690
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BioCheck S-TSH EIA is intended for the quantitative determination of thyrotropin, of thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the Biocheck Sensitive Thyroid Stimulating Hormone (S-TSH) Enzyme Immunoassay Test Kit. It details the regulatory clearance for the device but does not contain the acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than presenting performance data against predefined acceptance criteria for a new study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1