510(k) K123320 ยท JIF Enzymatic Method, Ammonia
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, Feb 15, 2013 |
| Received | Oct 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2017 | Siemens Healthcare Diagnostics, Inc. Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Terminated |
JIF | None listed |
| Dec 16, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Ammonia Flex reagent cartridge / AMM
Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry Terminated |
JIF | None listed |
| Dec 16, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Ammonia Flex reagent cartridge / AMM
Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chem Terminated |
JIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.