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510(k) K160538

Sysmex XN-L Automated Hematology Analyzer by Sysmex America, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2016
Date Received
February 26, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Sysmex America, Inc.

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  • K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer (April 23, 2018)
  • K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use (November 6, 2017)
  • K160541 — Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrat (October 21, 2016)

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  • K240402 — Cito CBC System (February 3, 2025)
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  • K240636 — HemoScreen Hematology Analyzer (May 2, 2024)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)