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510(k) K882767

SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM by Toa Medical Electronics USA, Inc. — Product Code GKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
July 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Automated Blood Cell Diluting
Device Class
Class I
Regulation Number
864.5240
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)
  • 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)

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  • K852373 — AD150, AUTOMATED HEMATOLOGY DILUTOR (July 5, 1985)
  • K842747 — HYCEL DILUTOR, VARIOUS MODELS/MULTI (October 1, 1984)
  • K842446 — DILU-MATIC 140 (September 6, 1984)