510(k) K132638 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 27, 2014 |
| Received | Aug 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2026 | Siemens Healthcare Diagnostics, Inc. Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. Open, Classified |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.