Data / Medical devices / United States / iXensor USA Inc
iXensor USA Inc: FDA-registered device maker in San Juan Capistrano, CA, United States, 3 510(k) clearances
iXensor USA Inc is registered with the FDA (registration 3017548799) in San Juan Capistrano, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 29, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017548799
- Address
- 29122 Rancho Viejo Rd Ste 212, San Juan Capistrano, CA, United States, 92675
- Owner or operator
- iXensor Co Ltd (10048224)
- Roles
- Complaint file establishment
- First device listed
- February 2, 2017
- Registered through
- 2026
- Brand names listed
- CVSHealth, Eveline, PixoTest
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Complaint file establishment | accessdata.fda.gov |
| Assay, Glycosylated Hemoglobin | LCP | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2019 | K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | Substantially Equivalent | Ixensor Co, Ltd. | accessdata.fda.gov |
| April 12, 2019 | K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | Substantially Equivalent | Ixensor Co, Ltd. | accessdata.fda.gov |
| November 2, 2017 | K163087 | PixoTest Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ixensor Company , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Assay, Glycosylated Hemoglobin
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Updated October 29, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.