510(k) K140859 ยท CEC Radioimmunoassay, Free Thyroxine
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Nov 26, 2014 |
| Received | Apr 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge Terminated |
JLW | None listed |
| May 5, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge Terminated |
JLW | None listed |
| Jun 4, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.