510(k) K060264 ยท JIY Photometric Method, Iron (Non-Heme)
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
| Applicant | Dade Behring, Inc., Newark, DE, US |
| Decision | Substantially Equivalent, Mar 8, 2006 |
| Received | Feb 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista IRON Flex reagent cartridges Terminated |
JIY | None listed |
| Aug 25, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension IRON Flex reagent cartridges Terminated |
JIY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.