510(k) K230790 ยท DHA System, Test, Human Chorionic Gonadotropin
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
| Applicant | Abbott Laboratories, Iriving TX, US |
| Decision | Substantially Equivalent, May 19, 2023 |
| Received | Mar 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230790
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.