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510(k) K912494

SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER by Toa Medical Electronics USA, Inc. — Product Code GKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1991
Date Received
June 5, 1991
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 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)
  • 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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