510(k) K051564 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Aug 22, 2005 |
| Received | Jun 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051564
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.