510(k) K972354 ยท GKZ Counter, Differential Cell
ABBOTT CELL-DYN 3200 SYSTEM
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Sep 16, 1997 |
| Received | Jun 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972354
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb).
Abbott Diagnostics Division, Santa Clara, CA 05054
Designed for in vitro diagnostic use in clini Terminated |
GKZ | None listed |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb).
Abbott Diagnostics Division, Santa Clara, CA 05054
Designed for in vitro diagnostic use in clini Terminated |
GKZ | None listed |
| 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 |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer for i Terminated |
GKZ | None listed |
| Sep 2, 2010 | Abbott Laboratories CELL-DYN 3200 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | None listed |
| Apr 3, 2007 | Abbott Laboratories CELL-DYN 3200 Diluent/Sheath Reagent,
List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Terminated |
GIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.