510(k) K010236 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 5, 2001 |
| Received | Jan 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010236
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.