510(k) K133728 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 24, 2014 |
| Received | Dec 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133728
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.