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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K001683
Device Name SYSMEX R-500
Applicant
SYSMEX CORPORATION OF AMERICA
ONE WILDLIFE WAY
LONG GROVE,  IL  60047 -9596
Applicant Contact NINA GAMPERLING
Correspondent
SYSMEX CORPORATION OF AMERICA
ONE WILDLIFE WAY
LONG GROVE,  IL  60047 -9596
Correspondent Contact NINA GAMPERLING
Regulation Number864.5200
Classification Product Code
GKL  
Date Received06/01/2000
Decision Date 08/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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