BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST

    K Number: K131931 · Decision Jul 26, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    223
    Applicant Total
    7
    Review Days
    29

    Basic Information

    Device Name
    CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
    K Number
    K131931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CHEMTRON BIOTECH, INC.
    Date Received
    June 27, 2013
    Decision Date
    July 26, 2013
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by CHEMTRON BIOTECH, INC.

    K Number Device Name
    K142580 Chemtrue Multi-Panel DOA DIP Card Tests
    K123844 CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
    K123080 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
    K121339 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS
    K111322 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
    K102203 CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS