LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K960195
    Device Name
    THYROCHEK ONE-STEP RAPID TSH ASSAY
    Manufacturer
    FRANKLIN DIAGNOSTICS, INC.
    Date Cleared
    1996-04-15

    (90 days)

    Product Code
    JLW
    Regulation Number
    862.1690
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRANKLIN DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a serum sample contains TSH in a concentration > 5 wW/ml.
    Device Description
    This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a serum sample contains TSH in a concentration > 5 wW/ml.
    Ask a Question

    Page 1 of 1