510(k) K061793 ยท JIY Photometric Method, Iron (Non-Heme)
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 7, 2006 |
| Received | Jun 26, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061793
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085)
The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) Terminated |
JIY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.