510(k) BK150307
- Device
- Automated Differential Cell Counter
- Applicant
- BD Biosciences
- 510(k) number
- BK150307
- Product code
- OYE
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2016-09-16
- Date received
- 2015-08-24
- Regulation
- 864.5220
- Classification name
- Flow Cytometric Reagents And Accessories.
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
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 |
| K201814 | 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 Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit | Becton, Dickinson and Company | 2020-09-28 |
| 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#
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