Product code KSL
- Device name
- Solution, Copper Sulfate For Specific Gravity Determinations
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.9320
- Review panel
- HE
- 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 |
| 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 |
| 00192024025692 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024025708 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024025715 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024025722 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024025746 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024025753 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024025760 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024025777 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024165244 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00304040006580 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040001516 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040001479 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 00304040001462 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |