510(k) K030513 ยท GKZ Counter, Differential Cell
CELL-DYN 1800 SYSTEM
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, May 12, 2003 |
| Received | Feb 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030513
| 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 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa Clara, CA Terminated |
GKZ | None listed |
| Mar 13, 2008 | Abbott Laboratories Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01. Abbott Laboratories, Santa Clara, CA 95054-1113 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.