510(k) K150403 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
ADVIA Centaur TSH3-Ultra
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, May 1, 2015 |
| Received | Feb 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2017 | Siemens Healthcare Diagnostics, Inc. ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests) Open, Classified |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.