510(k) K051215 ยท GKZ Counter, Differential Cell
CELL-DYN SAPPHIRE SYSTEM
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 21, 2005 |
| Received | May 12, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051215
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2023 | Abbott Laboratories Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer. Open, Classified |
GKZ | None listed |
| Sep 14, 2010 | Abbott Laboratories CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA Terminated |
GKZ | None listed |
| Sep 2, 2010 | Abbott Laboratories CELL-DYN Sapphire, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | None listed |
| Apr 23, 2009 | Abbott Laboratories Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA. Terminated |
GKZ | None listed |
| Nov 21, 2008 | Abbott Laboratories CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03
A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cell Terminated |
GKZ | None listed |
| Aug 21, 2008 | Abbott Laboratories CELL-DYN Sapphire Hematology Analyzer, List number 08H00-01, LIS/ Middleware Interface Specification, Abbott Diagnostics Division, Santa Clara, CA
For in vitro diagnostic use in counting and characte Terminated |
GKZ | None listed |
| May 14, 2008 | Abbott Laboratories White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Pa Terminated |
GGK | None listed |
| Apr 24, 2008 | Abbott Laboratories CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL. Terminated |
GKZ | None listed |
| Jan 4, 2008 | Abbott Laboratories Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wr Terminated |
GKZ | None listed |
| Apr 3, 2007 | Abbott Laboratories CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Terminated |
GIF | None listed |
| Mar 1, 2007 | Abbott Laboratories CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers. Terminated |
GIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.