510(k) K151529 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 11, 2016 |
| Received | Jun 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151529
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586 Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.