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510(k) K971736

SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER by Sysmex Corp. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
May 12, 1997
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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  • K945837 — SYSMEX(TM) F-820, 520 (June 9, 1995)
  • K942096 — TOA MEDICAL ELECTRONICS CA-1000 (March 24, 1995)

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