FDA Product Code
FDA Product Code QAX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5862
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261399 | ELISIO-HX | Nipro Medical Corporation | 2026-07-28 | Traditional | PDF ↗ |
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Baxter Healthcare Corporation | 2020-08-28 | Direct | — |
Product code QAX · Class II · Gastroenterology, Urology. Data: openFDA.