510(k) K061238 ยท KHS Enzymatic, Carbon-Dioxide
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 25, 2006 |
| Received | May 3, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determi Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.