Product code CEN
- Device name
- Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1550
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091287 | VS-SENSE TEST | Common Sense , Ltd. | 2009-08-31 |
| K071100 | AMNISCREEN HOME DETECTION LINER KIT | Common Sense , Ltd. | 2007-10-15 |
| K051727 | AIMSTICK URINE REAGENT STRIPS | Germaine Laboratories, Inc. | 2005-10-26 |
| K040008 | QUICKVUE ADVANCE PH AND AMINES GLL TEST | Quidel Corp. | 2004-04-29 |
| K030650 | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS | Uridynamics, Inc. | 2003-04-14 |
| K962718 | FEMEXAM TESTCARD | Litmus Concepts, Inc. | 1997-02-07 |
| K840827 | KYOTEST 5V | Kyoto Diagnostics, Inc. | 1984-05-14 |
| K830824 | URINE SCREENING KIT | Syn-Kit, Inc. | 1983-06-12 |
| K830979 | HELENA BIOSTRIP PH | Helena Laboratories | 1983-05-05 |
| K830091 | LITH A TEST TM | Lenal Creative Approaches, Inc. | 1983-02-15 |
| K822241 | FOLATE/B12 DUO-BEAD RADIOASSAY | Abbott Laboratories | 1982-10-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06935740751780 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751773 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751872 | URINE ANALYZER | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751865 | URINE ANALYZER | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751858 | Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751841 | Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751834 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751827 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751810 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751803 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751797 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 08806141303497 | One+Step 10A | DFI CO.,LTD | 2023-10-16 |
| 08806141303480 | One+Step UTI | DFI CO.,LTD | 2023-10-14 |
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 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 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 08806125680064 | URiSCAN 6 L strip | YD Diagnostics CORP. | 2016-09-01 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |