510(k) K043125 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
ORION DIAGNOSTICA UNIQ PINP RIA
| Applicant | Orion Diagnostica, OY, Espoo, FI |
| Decision | Substantially Equivalent, May 4, 2005 |
| Received | Nov 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043125
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.