510(k) K991605 ยท GKZ Counter, Differential Cell
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION
| Applicant | Abbott Laboratories, Santa Clara CA, US |
| Decision | Substantially Equivalent, Jul 9, 1999 |
| Received | May 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991605
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2011 | Abbott Laboratories CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS 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 3700SL Analyzer and CELL-DYN 3700SL 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 3500SL Analyzer and CELL-DYN 3500SL 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 Sheer Valve Assembly Driver
Abbott Diagnostics Division, Santa Clara, CA 05054 Terminated |
GKZ | None listed |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader), Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer Terminated |
GKZ | None listed |
| Mar 17, 2011 | Abbott Laboratories Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca
Medical Device, hematology analyzer for in Terminated |
GKZ | None listed |
| Sep 2, 2010 | Abbott Laboratories CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802. Terminated |
GKZ | None listed |
| Aug 29, 2007 | Abbott Laboratories Abbott CELL-DYN 3500 Hematology Analyzer Terminated |
GKZ | None listed |
| Aug 29, 2007 | Abbott Laboratories Abbott CELL-DYN 3700 Hematology Analyzer Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.