510(k) K971998 ยท GKL Counter, Cell, Automated (Particle Counter)
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Aug 29, 1997 |
| Received | May 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971998
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2013 | Siemens Healthcare Diagnostics ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 .
The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood count Terminated |
GKL | None listed |
| Aug 4, 2006 | Bayer Healthcare, LLC (Diagnostics Division) ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter Terminated |
GKL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.