510(k) K201814
- Device
- 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 Modu
- Applicant
- Becton, Dickinson And Company
- 510(k) number
- K201814
- Product code
- OYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-28
- Date received
- 2020-07-01
- Regulation
- 864.5220
- Classification name
- Flow Cytometric Reagents And Accessories.
- Medical specialty
- Hematology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Niya Su
- Address
- 2350 Qume Dr. San Jose CA US 95131 95131
FDA Registration Numbers#
- 1064130
- 8043379
- 3003244710
- 8023018
- 1017835
- 3016954941
- 3008352382
- 3008494306
- 3003589956
- 1061932
- 3027394506
Source Documents#
Other 510(k) Records For Product Code OYE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023-11-22 |
| K170974 | 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 | Becton, Dickinson and Company | 2017-07-03 |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser | Beckman Coulter | 2017-06-23 |
| K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS | Beckman Coulter, Inc. | 2015-04-10 |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) | Bd Biosciences | 2015-02-27 |
| K130373 | NAVIOS FLOW CYTOMETER SYSTEM | Beckman Coulter, Inc. | 2013-09-18 |
| K121445 | TETRACHROME REAGENTS AND TETRACXP SYSTEM | Beckman Coulter, Inc. | 2013-07-26 |
Legacy Summary#
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FDA Review#
Decision Summary