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510(k) K933886

TOA MEDICAL ELECTRONICS CA-5000 by Toa Medical Electronics USA, Inc. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
August 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Toa Medical Electronics USA, Inc.

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  • 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)
  • K894539 — SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER (September 26, 1989)

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