510(k) K073055 ยท JFY Enzymatic Method, Creatinine
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 3, 2008 |
| Received | Oct 30, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for t Terminated |
JFY | None listed |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 Terminated |
JFY | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Assays: ENZYMATIC CREATININE Terminated |
JFY | None listed |
| May 10, 2011 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Terminated |
JFY | None listed |
| Dec 13, 2008 | Dade Behring, Inc. Dimension Enzymatic Creatinine Flex reagent cartridge, DF270.
The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.