510(k) K162538 ยท JIT Calibrator, Secondary
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
| Applicant | Siemens Healthcare Diagnostics, East Walpole MA, US |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Sep 12, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162538
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.