510(k) K183592

Device: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
Applicant: Beckman Coulter
510(k) number: K183592
Product code: PWD
Decision: Substantially Equivalent (SESE)
Decision date: 2019-03-21
Date received: 2018-12-21
Regulation: 864.7010
Classification name: Flow Cytometric Test System For Hematopoietic Neoplasms
Medical specialty: Hematology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
15099590694968	ClearLLab 10C	BECKMAN COULTER IRELAND INC.	2019-04-05
15099590701505	ClearLLab 10C	BECKMAN COULTER IRELAND INC.	2019-03-26
15099590701499	ClearLLab 10C	BECKMAN COULTER IRELAND INC.	2019-03-26
15099590701482	ClearLLab 10C	BECKMAN COULTER IRELAND INC.	2019-03-26
15099590701475	ClearLLab 10C	BECKMAN COULTER IRELAND INC.	2019-03-26
15099590694982	ClearLLab 10C	BECKMAN COULTER IRELAND INC.	2019-03-26
15099590694975	ClearLLab 10C	BECKMAN COULTER IRELAND INC.	2019-03-26

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
DEN160047	ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M	Beckman Coulter	2017-06-29

Decision Summary