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510(k) K001683

SYSMEX R-500 by Sysmex Corporation of America — Product Code GKL

K001683 is an FDA 510(k) premarket notification submitted by Sysmex Corporation of America for the device "SYSMEX R-500". The FDA issued a decision of Substantially Equivalent on August 21, 2000. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Sysmex Corporation of America has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2000
Date Received
June 1, 2000
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 Corporation of America

  • K021241 — SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I (June 25, 2002)
  • K020496 — HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX S (April 12, 2002)

Other clearances for product code GKL

  • K152776 — Glocyte Automated Cell Counter System (May 27, 2016)
  • K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULE (August 31, 2010)
  • 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)
  • K991070 — COULTER Z2 ANALYZER (May 11, 1999)
  • K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 (November 3, 1998)
  • K981761 — SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER (August 14, 1998)

FDA data resources