510(k) K010066 ยท JPK Mixture, Hematology Quality Control
5C-ES CELL CONTROL, MODELS 7547191, 7547192
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Feb 7, 2001 |
| Received | Jan 8, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010066
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.