The following data is part of a premarket notification filed by Healthy.io Ltd with the FDA for Dip/u.s. Urine Analysis Test System.
| Device ID | K173327 |
| 510k Number | K173327 |
| Device Name: | DIP/U.S. Urine Analysis Test System |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | Healthy.io Ltd 27 Rothschild Boulevard Tel Aviv, IL 6688206 |
| Contact | Ron Zohar |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004 |
| Product Code | JIL |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-20 |
| Decision Date | 2018-07-18 |
| Summary: | summary |