510(k) K163271 ยท CGA Glucose Oxidase, Glucose
i-Stat Alinity System with i-Stat Glucose test
| Applicant | Abbott Point of Care, Inc., Princton NJ, US |
| Decision | Substantially Equivalent, Apr 10, 2017 |
| Received | Nov 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163271
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.