510(k) K083465 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Feb 27, 2009 |
| Received | Nov 24, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
CGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.