510(k) K150815 ยท PMG Automated Multicolor Fluorescent Imaging Cytometric Analysis System
BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
| Applicant | Becton, Dickinson and Company, San Jose CA, US |
| Decision | Substantially Equivalent, Dec 17, 2015 |
| Received | Mar 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150815
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2020 | Becton, Dickinson and Company, BD Biosciences BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry. Terminated |
JPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.