510(k) K173909 ยท PDJ Hemoglobin A1c Test System
Dimension Hemoglobin A1c Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 13, 2018 |
| Received | Dec 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173909
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.