Product code JMA
- Device name
- Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1095
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06935740751780 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751797 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751803 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751810 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751827 | URINE REAGENT STRIPS | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751834 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751841 | Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751858 | Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751865 | URINE ANALYZER | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751872 | URINE ANALYZER | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
| 06935740751773 | Urine Strips | Urit Medical Electronic Co., Ltd. | 2026-06-03 |
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| 10884389181973 | Medline | MEDLINE INDUSTRIES, INC. | 2022-04-13 |
| 10884389181959 | Medline | MEDLINE INDUSTRIES, INC. | 2021-09-16 |
| 10888277110403 | Medline | MEDLINE INDUSTRIES, INC. | 2020-08-21 |
| 10885380175589 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2020-07-09 |
| 10673486000672 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2020-03-09 |
| 08806141301479 | QTEST™ 11 | DFI CO.,LTD | 2018-12-21 |
| 10722355002917 | Detector UA 2GP | Immunostics Company, Inc | 2018-11-20 |
| 10722355002924 | Detector UA 10SG | Immunostics Company, Inc | 2018-11-20 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 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 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 10722355002221 | Detector UA 10 | Immunostics Company, Inc | 2016-09-26 |
| 10837461002529 | iChem | IRIS INTERNATIONAL, INC. | 2016-09-07 |
| 10837461002628 | iChem® VELOCITY™ | BECKMAN COULTER IRELAND INC. | 2016-09-07 |