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510(k) K992875

SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER by Sysmex Corp. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1999
Date Received
August 26, 1999
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 Corp.

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  • K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (August 14, 1998)
  • K971736 — SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER (August 26, 1997)
  • K964946 — SYSMEX CA-1000/SYSMEX CA-5000 (March 18, 1997)
  • K964375 — SYSMEX SE/RAM-1 (March 13, 1997)
  • K961054 — SYSMEX UF-100 (October 28, 1996)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)
  • K945837 — SYSMEX(TM) F-820, 520 (June 9, 1995)
  • K942097 — TOA MEDICAL ELECTRONICS CA-5000 (March 24, 1995)

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