510(k) K230878 ยท GKZ Counter, Differential Cell
QScout Lab; QScout RLD
| Applicant | Ad Astra Diagnostics, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Nov 14, 2023 |
| Received | Mar 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230878
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.