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510(k) K910745

HEMOGLOBIN REAGENT by Toa Medical Electronics USA, Inc. — Product Code GKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1991
Date Received
February 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemoglobin, Automated
Device Class
Class II
Regulation Number
864.5620
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)
  • 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)
  • K894539 — SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER (September 26, 1989)

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  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)