510(k) K100344 ยท MOI System, Test, Immunological, Antigen, Tumor
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Apr 18, 2011 |
| Received | Feb 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100344
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2022 | Siemens Healthcare Diagnostics, Inc. Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.
Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456 Open, Classified |
MOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.