Home / 510(k) Clearances / K883997

510(k) K883997

SYSMEX NE-8000 by Toa Medical Electronics USA, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1988
Date Received
September 20, 1988
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

Other clearances by Toa Medical Electronics USA, Inc.

  • K936023 — SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER (May 2, 1994)
  • K933886 — TOA MEDICAL ELECTRONICS CA-5000 (January 27, 1994)
  • K931149 — CA-1000 AUTOMATED COAGULATION ANALYZER (November 3, 1993)
  • K920544 — SYSMEX HEMATOLOGY SYSTEM ACCESSORIES (April 29, 1992)
  • K914744 — SYSMEX NE-1500, MODIFICATION (December 30, 1991)
  • K912494 — SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER (September 10, 1991)
  • K911173 — SYSMEX F-310 (July 26, 1991)
  • K910849 — SYSMEX F-810 (July 26, 1991)
  • K911172 — SYSMEX F-610 (July 26, 1991)
  • K910745 — HEMOGLOBIN REAGENT (July 11, 1991)

Other clearances for product code GKZ

  • K243348 — Athelas Home (February 6, 2026)
  • K251249 — Tru Hematology Test (January 16, 2026)
  • K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer (June 25, 2025)
  • K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer (June 25, 2025)
  • K243283 — Alinity h-series System (February 20, 2025)
  • K240402 — Cito CBC System (February 3, 2025)
  • K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer I (July 5, 2024)
  • K232946 — Yumizen H2500 (May 21, 2024)
  • K240636 — HemoScreen Hematology Analyzer (May 2, 2024)
  • K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (December 21, 2023)