510(k) K163342 ยท JPI Device, Hematocrit Measuring
i-STAT Hematocrit test with i-STAT Alinity System
| Applicant | Abbott Laboratories, Princton NJ, US |
| Decision | Substantially Equivalent, Aug 22, 2017 |
| Received | Nov 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163342
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.