FDA 510(k) Applications for Medical Device Product Code "JXA"
(Kit, Screening, Urine)

FDA 510(k) Number Applicant Device Name Decision Date
K972676 COMBACT DIAGNOSTIC SYSTEMS LTD. URINE SCREENING DEVICE 02/23/1998
K981084 DIATECH DIAGNOSTICS,INC. URISCREEN 10/07/1998
K011043 OSMETECH OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) 11/30/2001


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