510(k) K244014 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
i-STAT CG4+ cartridge with the i-STAT 1 System
| Applicant | Abbott Point of Care, Inc., Princton NJ, US |
| Decision | Substantially Equivalent, May 2, 2025 |
| Received | Dec 26, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K244014
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2025 | Abbott Point Of Care Inc. i-STAT CG4+ cartridge (white). List Number: 03P85-25. Open, Classified |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.