The following data is part of a premarket notification filed by Healthy.io Ltd. with the FDA for Minuteful - Kidney Test.
| Device ID | K210069 |
| 510k Number | K210069 |
| Device Name: | Minuteful - Kidney Test |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | Healthy.io Ltd. 2 Ibn Gabirol St. Tel Aviv, IL 6407702 |
| Contact | Ron Zohar |
| Correspondent | Ron Zohar Healthy.io Ltd. 8 Yitzhak Sadeh St. Tel Aviv, IL 6777508 |
| Product Code | JIR |
| Subsequent Product Code | JFY |
| Subsequent Product Code | KQO |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-11 |
| Decision Date | 2022-07-06 |