Company
Becton, Dickinson and Company, BD Bio Sciences
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2025 | Becton, Dickinson and Company, BD Bio Sciences BD Trucount Controls, 30 Test - REF: 340335 Open, Classified |
GKZ | None listed |
| Aug 1, 2025 | Becton, Dickinson and Company, BD Bio Sciences BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD Open, Classified |
GKZ | None listed |
| Jul 3, 2025 | Becton, Dickinson and Company, BD Bio Sciences REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation. Open, Classified |
GKZ | K040026 |
| Jul 3, 2025 | Becton, Dickinson and Company, BD Bio Sciences REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation. Open, Classified |
GKZ | K040026 |
| Dec 23, 2024 | Becton, Dickinson and Company, BD Bio Sciences FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 Open, Classified |
OYE | K170974 K201814 |
| 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 | K170974 K201814 |
| 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 | K170974 K201814 |
| 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 | K170974 K201814 |
| 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 | K170974 K201814 |
| Oct 3, 2024 | Becton, Dickinson and Company, BD Bio Sciences BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1.
Intended use: to prepare human s Open, Classified |
PER | None listed |