The following data is part of a premarket notification filed by Ixensor Company Ltd. with the FDA for Pixotest Blood Glucose Monitoring System.
| Device ID | K163087 |
| 510k Number | K163087 |
| Device Name: | PixoTest Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | iXensor Company Ltd. 9F, No. 473, Sec. 2, Tiding Blvd., Neihu Dist. Taipei City, TW 114 |
| Contact | Jamie Wu |
| Correspondent | Feng-yu Lee IVDD REGULATORY CONSULTANT 29222 Rancho Viejo Rd, Suite 218 San Jan Capistrano, CA 92675 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2017-11-02 |
| Summary: | summary |