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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K163406
Device Name Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
Applicant
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92121
Applicant Contact QIYI XIE
Correspondent
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92121
Correspondent Contact QIYI XIE
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
JGY   LBR  
Date Received12/05/2016
Decision Date 07/11/2017
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
Predetermined Change
Control Plan Authorized		 No
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