510(k) K200492 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, Apr 9, 2020 |
| Received | Feb 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200492
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.