510(k) K140790 ยท JIX Calibrator, Multi-Analyte Mixture
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jun 15, 2015 |
| Received | Mar 31, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140790
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2024 | Siemens Healthcare Diagnostics, Inc. Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; Open, Classified |
JGJ | None listed |
| Jan 28, 2022 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System.
The Dimension Vista Magnesium Flex Reagent (MG) method is an I Open, Classified |
JGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.