510(k) K090330 ยท JFY Enzymatic Method, Creatinine
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 22, 2009 |
| Received | Feb 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine Terminated |
JFY | None listed |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 Terminated |
JFY | None listed |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Assays: Enzymatic Creatine (ECRE) Terminated |
JFY | None listed |
| May 9, 2011 | Siemens Healthcare Diagnostics, Inc. Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System
The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in h Terminated |
JFY | None listed |
| Sep 16, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista ECREA Flex Reagent Cartridge
The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista Syst Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.