Panels › Hematology › Product code OYE · Class 2
Flow Cytometric Reagents And Accessories.
Regulation 864.5220
1510(k)s in 12 months (9 all time)
1recalls in 12 months (26 all time)
25recalls that name a 510(k)
Top companies in OYE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2025 | Beckman Coulter Inc. DxFLEX Flow Cytometer Catalog Number C78500
UDI-DI code: 15099590754013
The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent dete Open, Classified |
OYE | K232600 |
| 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 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| 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 | K170974 |
| Jan 29, 2018 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coul Terminated |
OYE | K141932 |
| Oct 2, 2017 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland.
The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic dev Terminated |
OYE | K141932 |
| Aug 21, 2017 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer System
The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. Terminated |
OYE | K141932 |
| Apr 17, 2017 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1
Product Usage:
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using u Terminated |
OYE | K141932 |
| Nov 21, 2016 | Beckman Coulter Inc. AQUIOS Lyse Reagent Kit, Catalog No. B23538
Product Usage:
AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytomete Terminated |
OYE | K141932 |
| Sep 28, 2016 | Beckman Coulter Inc. AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels. Terminated |
OYE | K141932 |
| Jun 26, 2015 | BD Biosciences, Systems & Reagents BD FACSCalibur;
Catalog Numbers 342973, 342975, 34976
In vitro Diagnostics Use. Terminated |
OYE | K980858 |
| Jul 2, 2014 | BD Biosciences, Systems & Reagents BD FACS Canto and associated Fluidics Cart
Product Usage: Flow cytometer for use in In vitro Diagnostics. Terminated |
OYE | None listed |
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