FDA 510(k) Applications for Medical Device Product Code "LJX"
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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 |