510(k) K261039 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
i-STAT Crea cartridge with the i-STAT 1 System
| Applicant | Abbott Point of Care, Inc., Princeton NJ, US |
| Decision | Substantially Equivalent, Jun 26, 2026 |
| Received | Mar 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261039
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.