FDA 510(k) Applications for Medical Device Product Code "LJX"
(Test, Urine Leukocyte)

FDA 510(k) Number Applicant Device Name Decision Date
K063295 ACON LABORATORIES, INC. ACON UTI URINARY TRACT INFECTION TEST STRIPS 10/12/2007
K981555 CHRONIMED, INC. DIASCREEN REAGENT STRIPS 06/01/1998
K971976 DIA-SCREEN CORP. DIASCREEN REAGENT STRIPS 06/17/1997
K231045 Healgen Scientific LLC Healgen URS Test Strips 06/16/2023
K000578 SERIM RESEARCH CORP. SERIM LEUKOCYTE ESTERASE TEST STRIPS 05/05/2000


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