510(k) K870233 ยท GKZ Counter, Differential Cell
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER
| Applicant | Abbott Diagnostics, Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 17, 1987 |
| Received | Jan 21, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2011 | Abbott Laboratories The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems.
Usage: Accessories to human waste container systems Terminated |
GKZ | None listed |
| May 20, 2010 | Abbott Laboratories CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA Terminated |
GKZ | None listed |
| May 20, 2010 | Abbott Laboratories CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA Terminated |
GKZ | None listed |
| Aug 18, 2007 | Abbott Laboratories CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 and 01H92-01 when Terminated |
GKZ | None listed |
| Aug 18, 2007 | Abbott Laboratories Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled medical device for diagnostic use and CELL DYN Control Assay Disk, LIst Numbers 01H91-01 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.