ClearanceBrief
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)
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Top companies in OYE

DateFirm and productCodeLinked 510(k)
Nov 18, 2025Beckman 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
OYEK232600
Dec 23, 2024Becton, Dickinson and Company, BD Bio Sciences
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181
Open, Classified
OYEK170974
K201814
Dec 23, 2024Becton, 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
OYEK170974
K201814
Dec 23, 2024Becton, 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
OYEK170974
K201814
Dec 23, 2024Becton, 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
OYEK170974
K201814
Dec 23, 2024Becton, 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
OYEK170974
K201814
Jul 12, 2024Becton, 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
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
Terminated
OYEK170974
Aug 19, 2019Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
Terminated
OYEK170974
Feb 1, 2019Becton, 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
OYEK170974
Jul 13, 2018Becton, 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
OYEK170974
Jan 29, 2018Beckman 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
OYEK141932
Oct 2, 2017Beckman 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
OYEK141932
Aug 21, 2017Beckman 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
OYEK141932
Apr 17, 2017Beckman 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
OYEK141932
Nov 21, 2016Beckman 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
OYEK141932
Sep 28, 2016Beckman 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
OYEK141932
Jun 26, 2015BD Biosciences, Systems & Reagents
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Terminated
OYEK980858
Jul 2, 2014BD Biosciences, Systems & Reagents
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Terminated
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