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510(k) K920544

SYSMEX HEMATOLOGY SYSTEM ACCESSORIES by Toa Medical Electronics USA, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1992
Date Received
February 6, 1992
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)
  • 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)
  • K911172 — SYSMEX F-610 (July 26, 1991)
  • K910849 — SYSMEX F-810 (July 26, 1991)
  • K910745 — HEMOGLOBIN REAGENT (July 11, 1991)
  • K894539 — SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER (September 26, 1989)

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