510(k) K925668 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM
| Applicant | E.I. Dupont DE Nemours & Co., Inc., Wilmington DE, US |
| Decision | Substantially Equivalent, Dec 28, 1992 |
| Received | Nov 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925668
| 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 |
| Jan 15, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Creatinine Flex(R) Reagent Cartridges.
The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vi Terminated |
CGX | None listed |
| Dec 27, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension(R) Creatinine Flex(R) Reagent Cartridges
The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vis Terminated |
CGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.