510(k) K081822 ยท JPK Mixture, Hematology Quality Control
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jan 21, 2009 |
| Received | Jun 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081822
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.