510(k) K053109 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 23, 2005 |
| Received | Nov 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053109
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.