510(k) K142993 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
| Applicant | Orion Diagnostica, OY, Oulu, FI |
| Decision | Substantially Equivalent, Mar 10, 2016 |
| Received | Oct 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142993
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.