510(k) K081300 ยท JHM Colorimetric Method, Lipoproteins
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Jul 2, 2008 |
| Received | May 8, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2022 | Siemens Healthcare Diagnostics, Inc. Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD
Siemens Material Number (SMN): 10464340
Catalog Number: K3048A Open, Classified |
JHM | None listed |
| Feb 3, 2021 | Siemens Healthcare Diagnostics, Inc. Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the a Open, Classified |
JHM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.