510(k) K221990 · DHA System, Test, Human Chorionic Gonadotropin
Access Total ßhCG (5th IS)
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 27, 2022 |
| Received | Jul 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221990
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.