510(k) K060502 ยท MLM Enzyme Immunoassay, Tracrolimus
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 18, 2006 |
| Received | Feb 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2013 | Siemens Healthcare Diagnostics, Inc. Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107)
Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in huma Terminated |
MLM | None listed |
| Mar 15, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test. Terminated |
MLM | None listed |
| Sep 13, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Newark, Delaware. Terminated |
MLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.