510(k) K061667 ยท GKZ Counter, Differential Cell
CELL-DYN RUBY SYSTEM
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 10, 2006 |
| Received | Jun 14, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061667
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-01
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | None listed |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-03
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | None listed |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-10
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | None listed |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-13
Software Version: All software versions
Product Description: CELL-DYN Ruby
Component: No Open, Classified |
GKZ | None listed |
| Apr 22, 2025 | Abbott Laboratories Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 04U42-84
Software Version: All software versions
Product Description: CELL-DYN Ruby Open, Classified |
GKZ | None listed |
| 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 |
| Mar 9, 2017 | Abbott Laboratories CELL-DYN Ruby System:
List Number: 08H6701;
Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories Terminated |
GKZ | None listed |
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer.
Abbott Diagnostics Division, Santa Clara, CA 05054 Terminated |
GKZ | None listed |
| Sep 2, 2010 | Abbott Laboratories CELL-DYN Ruby, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | None listed |
| May 22, 2009 | Abbott Laboratories Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01, Manufactured by Abbott Diagnostics Division, Santa Clara, CA.
Product is a multi-parameter automated hemato Terminated |
GKZ | None listed |
| Apr 10, 2009 | Abbott Laboratories CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01
The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instr Terminated |
GKZ | 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.