LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023032
    Device Name
    LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
    Manufacturer
    BIORESOURCE TECHNOLOGY, INC.
    Date Cleared
    2002-10-08

    (27 days)

    Product Code
    GFS
    Regulation Number
    864.8625
    Why did this record match?
    Product Code :

    GFS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Liquid Human Glycosylated Hemoglobin (A1C) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (A1C) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1