510(k) K233581 · DHA System, Test, Human Chorionic Gonadotropin
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Bridgend, GB |
| Decision | Substantially Equivalent, May 8, 2024 |
| Received | Nov 7, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233581
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.