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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, automated blood cell diluting
510(k) Number K100684
Device Name CELLTRACKS AUTOPREP SYSTEM MODEL:9541
Applicant
VERIDEX, LLC
1001 US HIGHWAY 202 NORTH
RARITAN,  NJ  08869 -0606
Applicant Contact SARAH MCMANUS
Correspondent
VERIDEX, LLC
1001 US HIGHWAY 202 NORTH
RARITAN,  NJ  08869 -0606
Correspondent Contact SARAH MCMANUS
Regulation Number864.5240
Classification Product Code
GKH  
Date Received03/10/2010
Decision Date 08/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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