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FDA 510(k)

NAVIOS FLOW CYTOMETER SYSTEM

K-Number: K130373 · 2013-09-18

ApplicantBeckman Coulter, Inc.
Decision Date2013-09-18
Product CodeOYE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NAVIOS FLOW CYTOMETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2013-09-18 under 510(k) number K130373. The device is classified under product code OYE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIOS FLOW CYTOMETER SYSTEM?

NAVIOS FLOW CYTOMETER SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-18. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K130373.

When did NAVIOS FLOW CYTOMETER SYSTEM receive FDA 510(k) clearance?

NAVIOS FLOW CYTOMETER SYSTEM received FDA 510(k) clearance on 2013-09-18, under 510(k) number K130373.

Who is the listed applicant for NAVIOS FLOW CYTOMETER SYSTEM?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIOS FLOW CYTOMETER SYSTEM?

The FDA product code for NAVIOS FLOW CYTOMETER SYSTEM is OYE.

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Related Devices (Code: OYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc.K201814BD 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 KitBecton, Dickinson and CompanyK170974BD 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 TBNKBecton, Dickinson and CompanyK162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 LaserBeckman CoulterK121445TETRACHROME REAGENTS AND TETRACXP SYSTEMBeckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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