LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062096
    Device Name
    KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
    Manufacturer
    KOREAMEDICO CO. LTD.
    Date Cleared
    2007-05-07

    (287 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOREAMEDICO CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Chextic is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1