510(k) K160647 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, May 31, 2016 |
| Received | Mar 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160647
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.