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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control material, blood circulating epithelial cancer cell
510(k) Number K040898
Device Name CELLSEARCH EPITHELIAL CELL CONTROL KIT
Applicant
VERIDEX, LLC
1001 US HWY 202
RARITAN,  NJ  08869 -0606
Applicant Contact DEBRA J RASMUSSEN
Correspondent
VERIDEX, LLC
1001 US HWY 202
RARITAN,  NJ  08869 -0606
Correspondent Contact DEBRA J RASMUSSEN
Regulation Number864.8625
Classification Product Code
NRS  
Date Received04/06/2004
Decision Date 06/28/2004
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
Recalls CDRH Recalls
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