510(k) K060090 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 27, 2006 |
| Received | Jan 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc Dimension Vista System TSH Flex Reagent Cartridge (REF K6412).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.