510(k) K162698 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer
| Applicant | Shenzhen New Industries Biomedical Engineering Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 14, 2017 |
| Received | Sep 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162698
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.