ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

K Number: DEN160047 · Decision Jun 29, 2017

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Device Name: ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
K Number: DEN160047
Device Class: FDA class 2
Clearance Type: Direct
Regulation Number: 864.7010
Medical Specialty: Hematology
Decision: Unknown
Applicant: Beckman Coulter
Date Received: October 3, 2016
Decision Date: June 29, 2017
Product Code: PWD
Advisory Committee: Hematology
Review Advisory Committee: IM
Third Party: N

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
PWD	Flow Cytometric Test System For Hematopoietic Neoplasms	FDA class 2	Hematology

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