ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer— 510(k) K183592

Substantially Equivalent

Beckman Coulter

FDA 510(k) clearance K183592 for ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer, Substantially Equivalent on 2019-03-21. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
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