510(k) K112755 ยท GKZ Counter, Differential Cell
ABACUS 5
| Applicant | Diatron U.S., Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Mar 27, 2012 |
| Received | Sep 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.