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510(k) K081610

SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER by Sysmex America, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2008
Date Received
June 9, 2008
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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  • K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use (November 6, 2017)
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