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510(k) K914744

SYSMEX NE-1500, MODIFICATION by Toa Medical Electronics USA, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
October 22, 1991
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.

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  • K931149 — CA-1000 AUTOMATED COAGULATION ANALYZER (November 3, 1993)
  • K920544 — SYSMEX HEMATOLOGY SYSTEM ACCESSORIES (April 29, 1992)
  • K912494 — SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER (September 10, 1991)
  • K911172 — SYSMEX F-610 (July 26, 1991)
  • K910849 — SYSMEX F-810 (July 26, 1991)
  • K911173 — SYSMEX F-310 (July 26, 1991)
  • K910745 — HEMOGLOBIN REAGENT (July 11, 1991)
  • K894539 — SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER (September 26, 1989)

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