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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose oxidase, glucose
510(k) Number K151530
Device Name CardioChek Plus Test System
Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 Zionsville Rd
INDIANAPOLIS,  IN  46268
Applicant Contact Megan Burns
Correspondent
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 Zionsville Rd
INDIANAPOLIS,  IN  46268
Correspondent Contact Megan Burns
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CHH   JGY   LBR  
Date Received06/08/2015
Decision Date 07/07/2015
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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