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510(k) Data Aggregation

    K Number
    K212418
    Device Name
    hCG One Step Pregnancy Test
    Manufacturer
    Healstone Biotech Inc.
    Date Cleared
    2022-06-30

    (331 days)

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

    Healstone Biotech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The hCG One Step Pregnancy Test is an in vitro diagnostic test for the qualitative determination of human chorionic gonadotropin hormone in human urine samples. It is used as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
    Device Description
    The hCG One Step Pregnancy Test is a lateral flow sandwich immunochromatographic assay for the qualitative determination of human chorionic gonadotropin (hCG) in human urine samples.
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