510(k) K961439 ยท GKZ Counter, Differential Cell
ABBOTT CELL-DYN 4000 SYSTEM
| Applicant | Abbott Diagnostics, Santa Clara CA, US |
| Decision | Substantially Equivalent, Oct 18, 1996 |
| Received | Apr 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2011 | Abbott Laboratories CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA
Medical dev 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 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 17, 2007 | Abbott Laboratories CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Distributed and Manufactured by:
Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA Terminated |
GIF | None listed |
| Mar 16, 2007 | Abbott Laboratories CELL-DYN 4000 Diluent/Sheath Reagent,
List Number 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 |
| Mar 13, 2003 | Abbott Laboratories Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT
Model/List Number 01H73-01 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.