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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K113830
Device Name VANTERA CLINICAL ANALYZER
Original Applicant
LIPOSCIENCE
2500 summer blvd.
raleigh,  NC  27616
Original Contact suzette warner
Regulation Number862.1705
Classification Product Code
CDT  
Subsequent Product Codes
LBS   MRR   NSU  
Date Received12/27/2011
Decision Date 08/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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