510(k) K230937 · DHA System, Test, Human Chorionic Gonadotropin
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
| Applicant | Abbott Laboratories, Iriving TX, US |
| Decision | Substantially Equivalent, Jun 5, 2023 |
| Received | Apr 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230937
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.