The following data is part of a premarket notification filed by Scanadu, Inc. with the FDA for Inui In-home Urine Analysis Test System.
| Device ID | K180356 |
| 510k Number | K180356 |
| Device Name: | Inui In-Home Urine Analysis Test System |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | Scanadu, Inc. 1196 Borregas Ave., Ste 200 Sunnyvale, CA 94089 |
| Contact | Daya Ranamukhaarachchi |
| Correspondent | Daya Ranamukhaarachchi Scanadu, Inc. 1196 Borregas Ave., Ste 200 Sunnyvale, CA 94089 |
| Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JMT |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2018-05-25 |
| Summary: | summary |