ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M— 510(k) DEN160047

Name: FDA 510(k) clearance DEN160047
Creator: U.S. Food and Drug Administration
Published: 2017-06-29

Unknown

Beckman Coulter

FDA 510(k) clearance DEN160047 for ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M, Unknown on 2017-06-29. Applicant: Beckman Coulter. Device class: 2.

Clearance details

Applicant: Beckman Coulter
Product code: Code PWD
Device class: Class 2
Regulation: 21 CFR 864.7010
Advisory panel: Hematology
Date received: 2016-10-03
Decision date: 2017-06-29
Decision: Unknown
Clearance type: Direct
Location: Miami, FL, US

View on FDA.gov ↗

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