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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK160282
Test Name SD Biosensor USA, Inc., SD LipidoCare Home System  {SD LipidoCare Home Lipid Panel Test Strip} 
Manufacturer NameSd Biosensor
Consumer Information Phone Number1(855)486-2888
Test TypeHDL cholesterol
Effective Date10/23/2017
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K160282
Device Name SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System
Applicant
Sd Biosensor
C-4th & 5th, 16, Deogyeong-Daero,
1556beon-Gil, Yeongtong-Gu,
Suwon-Si,  KR 443-813
Applicant Contact Sunok Go
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CHH   JGY   LBR  
Date Received02/02/2016
Decision Date 10/17/2017
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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