The following data is part of a premarket notification filed by Ixensor Co., Ltd. with the FDA for Pixotest Poct System - Pixotest Poct Analyzer And Pixotest A1c Test Kit.
| Device ID | K181915 |
| 510k Number | K181915 |
| Device Name: | PixoTest POCT System - PixoTest POCT Analyzer And PixoTest A1c Test Kit |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | iXensor Co., LTD. 6F., No.9 Aly. 2, Ln. 35, Jihu Road. Neihu Dist. Taipei, TW 114 |
| Contact | Ariel Huang |
| Correspondent | Feng-yu Lee IVDD Regulatory Consultant 29222 Rancho Viejo Rd., Suite 218 San Juan Capistrano, CA 92675 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-17 |
| Decision Date | 2019-04-12 |