510(k) K081857 ยท NRP Sirolimus Test System
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Oct 30, 2008 |
| Received | Jul 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Sirolimus (SIRO) Flex reagent cartridge Terminated |
NRP | None listed |
| Feb 9, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability
The SIRO method is an in vitro diagnostic test for the quantitative Terminated |
NRP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.