510(k) K171103 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Lumipulse G TSH-III Immunoreaction Cartridges
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jul 28, 2017 |
| Received | Apr 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171103
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.