FDA 510(k) Applications for Medical Device Product Code "JIO"
(Blood, Occult, Colorimetric, In Urine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K111221 | ACON LABORATORIES, INC. | MISSION U500 URINE ANALYZER | 01/18/2012 |
| K040703 | DIRUI INDUSTRIAL CO., LTD. | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS | 08/26/2004 |
| K111999 | HEALGEN SCIENTIFIC, LLC | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL | 04/17/2012 |
| K023297 | TECO DIAGNOSTICS | URS-1B (BLOOD TEST) | 03/06/2003 |
| K082811 | URIT MEDICAL ELECTRONIC CO., LTD. | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS | 09/11/2009 |
| K083724 | WIENER LABORATORIOS S.A.I.C. | WIENER LAB. URINE STRIP 10 AND 11 | 09/02/2009 |
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