510(k) K223857 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
i-STAT G3+ cartridge with the i-STAT 1 System
| Applicant | Abbott Point of Care, Inc., Princton NJ, US |
| Decision | Substantially Equivalent, Sep 15, 2023 |
| Received | Dec 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2026 | Abbott Point Of Care Inc. i-STAT G3+ cartridge;
List Number: 03P78-26; Open, Classified |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.