510(k) K110303 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
STRATUS CS ACUTE CARE D-DIMER
| Applicant | Siemens Healthcare Diagnostics, Newark DE, US |
| Decision | Substantially Equivalent, May 16, 2011 |
| Received | Feb 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110303
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care DDMR TestPak
Catalog Number: CDDMRE
SMN: 10701511
in vitro diagnostic Terminated |
DAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.