510(k) K210958 ยท CGA Glucose Oxidase, Glucose
i-STAT CHEM8+ cartridge with the i-STAT 1 System
| Applicant | Abbott Point of Care, Inc., Princton NJ, US |
| Decision | Substantially Equivalent, Aug 13, 2021 |
| Received | Mar 31, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210958
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.