510(k) K042442 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE
| Applicant | Orion Diagnostica, OY, Espoo, FI |
| Decision | Substantially Equivalent, Sep 24, 2004 |
| Received | Sep 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042442
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.