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510(k) Data Aggregation

    K Number
    K973957
    Device Name
    DBEST ONE-STEP HCG SERUM/URINE TEST
    Manufacturer
    AMERITEK, INC.
    Date Cleared
    1997-12-17

    (62 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DBEST ONE-STEP HCG SERUM/URINE TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The dBest One-Step hCG Serum/Urine Test is a immunoassay designed for the qualitative determination of the human chorionic gonadotropin (hCG) in serum/urine for the early detection of pregnancy. It is intended for professional and laboratory use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text includes a 510(k) premarket notification letter from the FDA regarding "dBest One-Step hCG Serum/Urine Dipstick and Cassette Pregnancy Test Kits." However, it does not contain the specific acceptance criteria or the study details that prove the device meets those criteria.

    The letter primarily concerns the substantial equivalence determination for the device, allowing it to be marketed. It does not elaborate on the performance data or the methods used to establish that performance.

    Therefore, I cannot provide the requested information based on the input text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, the full 510(k) submission, or a study report for the device.

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