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510(k) K945837

SYSMEX(TM) F-820, 520 by Sysmex Corp. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1995
Date Received
November 29, 1994
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

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  • K964946 — SYSMEX CA-1000/SYSMEX CA-5000 (March 18, 1997)
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  • K961054 — SYSMEX UF-100 (October 28, 1996)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)
  • K942097 — TOA MEDICAL ELECTRONICS CA-5000 (March 24, 1995)

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