510(k) K003419 ยท DCN System, Test, C-Reactive Protein
RCRP FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Feb 14, 2001 |
| Received | Nov 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2009 | Siemens Healthcare Diagnostics, Inc. Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP).
In vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Mea Terminated |
DCN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.