510(k) K201814 ยท OYE Flow Cytometric Reagents And Accessories.
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD F
| Applicant | Becton, Dickinson and Company, San Jose CA, US |
| Decision | Substantially Equivalent, Sep 28, 2020 |
| Received | Jul 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2024 | Becton, Dickinson and Company, BD Bio Sciences FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756
BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following:
" Immunophenotyping using up to six fluores Open, Classified |
OYE | None listed |
| Dec 23, 2024 | Becton, Dickinson and Company, BD Bio Sciences Device Description:
FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763
The K170974 clearance document describes the device as follows:
The BD FACSLyric" flow cytometer (3-1, 4 Open, Classified |
OYE | None listed |
| Dec 23, 2024 | Becton, Dickinson and Company, BD Bio Sciences FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770
The K170974 clearance document describes the device as follows:
The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3 Open, Classified |
OYE | None listed |
| Dec 23, 2024 | Becton, Dickinson and Company, BD Bio Sciences FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787
The K170974 clearance document describes the device as follows:
The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4- Open, Classified |
OYE | None listed |
| Dec 23, 2024 | Becton, Dickinson and Company, BD Bio Sciences FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 Open, Classified |
OYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.