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510(k) Data Aggregation

    K Number
    K974851
    Device Name
    SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
    Manufacturer
    SAN DIEGO BIOTECH
    Date Cleared
    1998-01-22

    (24 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The San Diego Biotech HCG Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. THIS TEST IS INTENDED FOR PROFESSIONAL AND LABORATORY USE ONLY.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an indication for use statement for the San Diego Biotech hCG Pregnancy Test. It does not include information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details. This information would typically be found in the device's 510(k) premarket notification or associated technical documentation, which is not provided in the input.

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