510(k) K153538 ยท GKZ Counter, Differential Cell
Dextramer CMV Kit
| Applicant | Immudex Aps, Copenhagen/Kobenhavn, DK |
| Decision | Substantially Equivalent, Mar 2, 2017 |
| Received | Dec 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153538
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.