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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 K162282
Device Name CardioChek Plus Test System, CardioChek Home Test System
Applicant
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
7736 Zionsville Road
Indianapolis,  IN  46268
Applicant Contact Margo Enright
Correspondent
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
7736 Zionsville Road
Indianapolis,  IN  46268
Correspondent Contact Margo Enright
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CHH   LBR   NBW  
Date Received08/15/2016
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 Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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