510(k) K063356 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Mar 23, 2007 |
| Received | Nov 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002
The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro Terminated |
DAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.