510(k) K160429 ยท GKZ Counter, Differential Cell
BC-5390 Auto Hematology Analyzer
| Applicant | Mindray Bio-Medical Electronics Co., Ltd., Nanshan, CN |
| Decision | Substantially Equivalent, Sep 1, 2016 |
| Received | Feb 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160429
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.