510(k) K022176 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257
| Applicant | Orion Diagnostica, Div. Orion Corp., Espoo, FI |
| Decision | Substantially Equivalent, Dec 3, 2002 |
| Received | Jul 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022176
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.