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 | K192369 |
| 510k Number | K192369 |
| 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 City, TW 114 |
| Contact | Evita Chen |
| Correspondent | Feng-yu Lee IVDD Regulatory Consultant 29122 Rancho Viejo Rd., Suite 212 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 | 2019-08-30 |
| Decision Date | 2019-10-29 |
| Summary: | summary |