510(k) K192547 · DHA System, Test, Human Chorionic Gonadotropin
MAGLUMI 2000 HCG/ß-HCG
| Applicant | Shenzhen New Industries Biomedical Engineering Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 17, 2020 |
| Received | Sep 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192547
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.