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510(k) Data Aggregation

    K Number
    K981892
    Device Name
    QUICK & SURE ONESTEP HOME PREGNANCY TEST
    Manufacturer
    ABACUS DIAGNOSTICS
    Date Cleared
    1998-08-18

    (81 days)

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

    ABACUS DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Quick & Sure Onestep Home Pregnancy Test is the Abacus Diagnostics name for an "over-the-counter" (OTC) solid phase immunoassay in vitro diagnostic test kit for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an indicator of Pregnancy.
    Device Description
    Not Found
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