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510(k) K981761

SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER by Sysmex Corp. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1998
Date Received
May 19, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Cell, Automated (Particle Counter)
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Sysmex Corp.

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  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 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)
  • K942096 — TOA MEDICAL ELECTRONICS CA-1000 (March 24, 1995)

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  • K071652 — HEMOCUE WBC SYSTEM (October 25, 2007)
  • K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (December 7, 2005)
  • K050235 — IQ 200 URINE ANALYZER BODY FLUIDS MODULE (March 23, 2005)
  • K032677 — SYSMEX POCH-100I (February 11, 2004)
  • K022331 — ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD (September 11, 2002)
  • K001683 — SYSMEX R-500 (August 21, 2000)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)