| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2023-09-08 | K222921 | Minuteful-kidney test | Healthy.io Ltd. | Clinical Chemistry |
| 2023-06-29 | DEN200052 | KidneyIntelX.dkd | Renalytix AI, Inc. | Clinical Chemistry |
| 2022-07-06 | K210069 | Minuteful - kidney test | Healthy.io Ltd. | Clinical Chemistry |
| 2019-07-26 | K182384 | ACR LAB Urine Analysis Test System | Healthy.io Ltd | Clinical Chemistry |
| 2019-07-18 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes Ltd | Clinical Chemistry |
| 2018-07-18 | K173327 | DIP/U.S. Urine Analysis Test System | Healthy.io Ltd | Clinical Chemistry |
| 2018-06-12 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | Clinical Chemistry |
| 2016-11-30 | K161834 | One Drop Blood Glucose Monitoring System | AgaMatrix, Inc. | Clinical Chemistry |
| 2015-12-21 | K150817 | Dario Blood Glucose Monitoring System | LabStyle Innovations Ltd. | Clinical Chemistry |