510(k) K081731 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Aug 29, 2008 |
| Received | Jun 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081731
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (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.