510(k) K042625 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
QUIKREAD CRP CALIBRATOR SET
| Applicant | Orion Diagnostica, OY, Espoo, FI |
| Decision | Substantially Equivalent, Nov 18, 2004 |
| Received | Sep 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042625
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.