510(k) K052002 ยท JIT Calibrator, Secondary
IRON STANDARD
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 22, 2005 |
| Received | Jul 25, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052002
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.