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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 K151545
Device Name CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 ZIONSVILLE ROAD
INDIANAPOLIS,  IN  46268
Applicant Contact MARGO ENRIGHT
Correspondent
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 ZIONSVILLE ROAD
INDIANAPOLIS,  IN  46268
Correspondent Contact MARGO ENRIGHT
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
JGY   LBR  
Date Received06/09/2015
Decision Date 12/22/2016
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
Recalls CDRH Recalls
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