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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 U.S. Hwy. 202 N.
Raritan,  NJ  08869
Applicant Contact SARAH MCMANUS
Correspondent
Veridex, LLC
1001 U.S. Hwy. 202 N.
Raritan,  NJ  08869
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
Predetermined Change
Control Plan Authorized		 No
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