510(k) K143720 ยท JHY Colorimetric Method, Cpk Or Isoenzymes
Dimension Vista MMB Assay
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Sep 18, 2015 |
| Received | Dec 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2021 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal Terminated |
JJE | None listed |
| Oct 15, 2021 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal Terminated |
JJE | None listed |
| Dec 12, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 Terminated |
JJE | None listed |
| Oct 16, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to dete Terminated |
JJE | None listed |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge Terminated |
JHY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.