510(k) K082162 ยท JPK Mixture, Hematology Quality Control
COULTER BODY FLUID CONTROL
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Feb 3, 2009 |
| Received | Jul 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082162
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.