Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser

FDA 510(k) clearance K162897 · decided 2017-06-23

Clearance details

K-number: K162897
Device name: Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
Applicant: Beckman Coulter
Decision: Substantially Equivalent
Date received: 2016-10-17
Decision date: 2017-06-23
Days to decision: 249 days
Clearance type: Traditional
Product code: OYE
Device class: 2
Regulation number: 864.5220
Medical specialty: Hematology
Advisory committee: Hematology
Location: Miami, FL, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
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 Company	2020-09-28
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 Company	2017-07-03
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 Biosciences	2015-02-27
NAVIOS FLOW CYTOMETER SYSTEM (K130373)	Beckman Coulter, Inc.	2013-09-18
TETRACHROME REAGENTS AND TETRACXP SYSTEM (K121445)	Beckman Coulter, Inc.	2013-07-26

No recalls on record reference this clearance.