Atlas FDA

OYE

8 FDA 510(k) clearances · Product code

249 daysmedian time to decision
437 days90th percentile
8clearances measured

FDA profile

Official device name
Flow Cytometric Reagents And Accessories.
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5220
Medical specialty
Hematology
Flags
Third-party review eligible
FDA definition
To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
Adverse events (MAUDE)
2020: 173 · 2021: 251 · 2022: 193 · 2023: 141 · 2024: 35 · 2025: 40
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600)Beckman Coulter, Inc.2023-11-22
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 (K201814)Becton, Dickinson and Company2020-09-28
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 (K170974)Becton, Dickinson and Company2017-07-03
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (K162897)Beckman Coulter2017-06-23
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS (K141932)Beckman Coulter, Inc.2015-04-10
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (K141468)Bd Biosciences2015-02-27
NAVIOS FLOW CYTOMETER SYSTEM (K130373)Beckman Coulter, Inc.2013-09-18
TETRACHROME REAGENTS AND TETRACXP SYSTEM (K121445)Beckman Coulter, Inc.2013-07-26

Track OYE automatically

Every clearance here is in the API, with alerts when new ones post.