510(k) K061802 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 11, 2006 |
| Received | Jun 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061802
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.