The following data is part of a premarket notification filed by Healthy.io Ltd with the FDA for Acr Lab Urine Analysis Test System.
| Device ID | K182384 |
| 510k Number | K182384 |
| Device Name: | ACR LAB Urine Analysis Test System |
| Classification | Enzymatic Method, Creatinine |
| Applicant | Healthy.io Ltd 2 Ibn Gabirol Tel Aviv, IL 6407702 |
| Contact | Ron Zohar |
| Correspondent | Ron Zohar Healthy.io Ltd 2 Ibn Gabirol Tel Aviv, IL 6407702 |
| Product Code | JFY |
| Subsequent Product Code | JIR |
| Subsequent Product Code | KQO |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-31 |
| Decision Date | 2019-07-26 |
| Summary: | summary |