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510(k) K964375

SYSMEX SE/RAM-1 by Sysmex Corp. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1997
Date Received
November 1, 1996
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)
  • 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)
  • 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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  • 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)