510(k) K111534 ยท GKZ Counter, Differential Cell
ABACUS 3CP
| Applicant | Diatron U.S., Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Aug 2, 2012 |
| Received | Jun 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111534
| 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 |
| Mar 10, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD
The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.