LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031271
    Device Name
    ONE-STEP PREGNANCY TEST
    Manufacturer
    AMERISOURCE PHARMACAL, INC.
    Date Cleared
    2003-06-17

    (56 days)

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

    AMERISOURCE PHARMACAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-The -Counter l Jse.
    Device Description
    The One-Step Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test will be sold for under private label in the Over-the-Counter Market.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1