Product code JIO
- Device name
- Blood, Occult, Colorimetric, In Urine
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.6550
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Urit Medical Electronic Co., Ltd. | 2024-04-26 |
| K111999 | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL | Healgen Scientific,, LLC | 2012-04-17 |
| K111221 | MISSION U500 URINE ANALYZER | ACON Laboratories, Inc. | 2012-01-18 |
| K082811 | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS | Urit Medical Electronic Co., Ltd. | 2009-09-11 |
| K083724 | WIENER LAB. URINE STRIP 10 AND 11 | Wiener Laboratorios Saic | 2009-09-02 |
| K040703 | URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS | Dirui Industrial Co., Ltd. | 2004-08-26 |
| K023297 | URS-1B (BLOOD TEST) | Teco Diagnostics | 2003-03-06 |
| K921495 | DIA STRIPS SYSTEM, MODIFIED | Symcon Intl., Inc. | 1992-07-21 |
| K913005 | BACTIDROP(TM) LACTOPHENOL ANILINE BLUE | Remel Co. | 1991-09-16 |
| K905396 | HEMASTIX REAGENT STRIPS | Heraeus Kulzer, Inc. | 1991-02-11 |
| K893894 | CHARISE CHARLES REAGENT BLOOD STRIPS | Lee Import Domestic Consulting | 1989-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10612479279886 | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-09-18 |
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141301998 | Yodoc 10 | DFI CO.,LTD | 2020-02-20 |
| 08806141301479 | QTEST™ 11 | DFI CO.,LTD | 2018-12-21 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 10673486000399 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000382 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000375 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000368 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 10673486000351 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415001294 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 10673486000016 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000023 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000030 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000047 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000054 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000061 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000078 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 08806125680064 | URiSCAN 6 L strip | YD Diagnostics CORP. | 2016-09-01 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |