510(k) K100778 ยท JIX Calibrator, Multi-Analyte Mixture
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, May 5, 2010 |
| Received | Mar 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100778
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.