510(k) K062087 ยท GKZ Counter, Differential Cell
BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
| Applicant | Bd Biosciences, San Jose CA, US |
| Decision | Substantially Equivalent, Sep 14, 2006 |
| Received | Jul 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2015 | BD Biosciences, Systems & Reagents BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway Terminated |
GKZ | None listed |
| Aug 16, 2008 | BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609
Flexible data acquistion and analysis package specifically designed for digital-based Terminated |
GKZ | None listed |
| Aug 8, 2008 | BD Biosciences BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System
Model/Catalog number 642685
Software is used to simplify acquisition of flow cytometry data. Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.