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 |