Panels › Hematology › Product code JIO · Class 2
Blood, Occult, Colorimetric, In Urine
Regulation 864.6550
0510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JIO
| Company | 510(k)s | Recalls |
|---|---|---|
| Urit Medical Electronic Co., Ltd. | 2 | 0 |
| ACON Laboratories, Inc. | 1 | 0 |
| Dirui Industrial Co., Ltd. | 1 | 0 |
| Healgen Scientific,, LLC | 1 | 0 |
| Heraeus Kulzer, Inc. | 1 | 0 |
| Lee Import Domestic Consulting | 1 | 0 |
| Remel Co. | 1 | 0 |
| Symcon Intl., Inc. | 1 | 0 |
| Teco Diagnostics | 1 | 0 |
| Wiener Laboratorios Saic | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 26, 2024 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips Urit Medical Electronic Co., Ltd., CN | JIO |
| Apr 17, 2012 | K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL Healgen Scientific,, LLC | JIO |
| Jan 18, 2012 | K111221 | MISSION U500 URINE ANALYZER ACON Laboratories, Inc. | JIO |
| Sep 11, 2009 | K082811 | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS Urit Medical Electronic Co., Ltd. | JIO |
| Sep 2, 2009 | K083724 | WIENER LAB. URINE STRIP 10 AND 11 Wiener Laboratorios Saic, AR | JIO |
| Aug 26, 2004 | K040703 | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS Dirui Industrial Co., Ltd. | JIO |
| Mar 6, 2003 | K023297 | URS-1B (BLOOD TEST) Teco Diagnostics | JIO |
| Jul 21, 1992 | K921495 | DIA STRIPS SYSTEM, MODIFIED Symcon Intl., Inc. | JIO |
| Sep 16, 1991 | K913005 | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE Remel Co. | JIO |
| Feb 11, 1991 | K905396 | HEMASTIX REAGENT STRIPS Heraeus Kulzer, Inc. | JIO |
| Jul 27, 1989 | K893894 | CHARISE CHARLES REAGENT BLOOD STRIPS Lee Import Domestic Consulting | JIO |
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