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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrumentation For Clinical Multiplex Test Systems
510(k) Number K133849
FOIA Releasable 510(k) K133849
Device Name VANTERA CLINICAL ANALYZER
Applicant
Liposcience
2500 Summer Blvd.
Raleigh,  NC  27616
Applicant Contact SUZETTE WARNER
Correspondent
Liposcience
2500 Summer Blvd.
Raleigh,  NC  27616
Correspondent Contact SUZETTE WARNER
Regulation Number862.2570
Classification Product Code
NSU  
Subsequent Product Codes
CDT   LBS   MRR  
Date Received12/19/2013
Decision Date 10/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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