LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991067
    Device Name
    MODIFICATION OF: DAVIDSTRIP HCG
    Manufacturer
    SIMEX MEDICAL, INC.
    Date Cleared
    1999-04-27

    (28 days)

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

    SIMEX MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DavidStrip hCG is a qualitative, two site sandwich immunoassay test kit for the rapid determination of hCG concentration in urine for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for professional use only.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1