PixoTest POCT System - PixoTest POCT Analyzer And PixoTest A1c Test Kit
IXensor Co. Ltd.
IXENSOR CO LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011061417 | 3011061417 | IXENSOR CO LTD | 1 | N | 2026-01-01 | 11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd., Neihu Dist, Taipei TW 114 |
| 3014683113 | 3014683113 | IXENSOR CORP | 1 | Y | 2020-04-25 | 29122 Rancho Viejo Road, Suite 212 San Juan Capistrano CA US 92675 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 178228 | 1017936864 | K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | 2019-10-29 |
| 220718 | 1038401789 | K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | 2019-10-29 |
| 178228 | 1593583494 | K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | 2019-04-12 |
| 220718 | 1715505703 | K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | 2019-04-12 |
| 220718 | 1063135335 | K163087 | PixoTest Blood Glucose Monitoring System | NBW | 2017-11-02 |
| 178228 | 1991260008 | K163087 | PixoTest Blood Glucose Monitoring System | NBW | 2017-11-02 |
| 220718 | 1139591487 | ||||
| 178228 | 1205824487 | ||||
| 178228 | 1290123714 | ||||
| 178228 | 1407348632 | ||||
| 178228 | 1506529835 | ||||
| 178228 | 1960363389 |
Product Codes Associated With Registrations#
PMN#
PixoTest POCT System - PixoTest POCT Analyzer And PixoTest A1c Test Kit
IXensor Co., LTD.
PixoTest Blood Glucose Monitoring System
IXensor Company Ltd.