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In this section: Substantially Equivalent 510(k) Device Information

BK210631 - Sysmex XN-10 Automated Hematology Analyzer

510(k) Number: BK210631
Applicant: Sysmex America, Inc.
Device Name: Sysmex XN-10 Automated Hematology Analyzer
Decision Date: 5/23/2022

Supporting Documents

BK210631 Letter
BK210631 Summary

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