510(k) K050191 ยท PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
| Applicant | Becton, Dickinson & CO, San Jose CA, US |
| Decision | Substantially Equivalent, Feb 22, 2005 |
| Received | Jan 27, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050191
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for us Terminated |
PER | None listed |
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intende Terminated |
PER | None listed |
| Jun 30, 2010 | BD Biosciences, Systems & Reagents BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis Terminated |
GKZ | None listed |
| Apr 10, 2008 | BD Biosciences BD FACS Sample Prep Assistant II, Part Number: 337170;
Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131 Terminated |
GKI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.