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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
510(k) Number K132711
Device Name CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
Applicant
CAROLINA LIQUID CHEMISTRIES CORP.
575 N. PATTERSON AVE.
SUITE 430
WINSTON-SALEM,  NC  27101
Applicant Contact PHILIP G SHUGART
Correspondent
CAROLINA LIQUID CHEMISTRIES CORP.
575 N. PATTERSON AVE.
SUITE 430
WINSTON-SALEM,  NC  27101
Correspondent Contact PHILIP G SHUGART
Regulation Number862.1475
Classification Product Code
LBS  
Date Received08/29/2013
Decision Date 05/08/2014
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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