510(k) K170974 ยท OYE Flow Cytometric Reagents And Accessories.
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
| Applicant | Becton, Dickinson and Company, San Jose CA, US |
| Decision | Substantially Equivalent, Jul 3, 2017 |
| Received | Apr 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170974
| 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 |
| Jul 12, 2024 | Becton, Dickinson and Company, BD Biosciences BD Multitest 6-Color TBNK CE-IVD, REF: 644611;
BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;
BD Multitest 6-Color TBNK, IVD, REF: 662967;
BD Multitest 6-Color TBNK Kit with Open, Classified |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes Terminated |
OYE | None listed |
| Feb 1, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878
BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for Terminated |
OYE | None listed |
| Jul 13, 2018 | Becton, Dickinson and Company, BD Biosciences BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jos Terminated |
OYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.