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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K193406
Device Name CardioChek Plus Test System; CardioChek Plus Home Test System
Applicant
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
4600 Anson Boulevard
Whitestown,  IN  46075
Applicant Contact Margo Enright
Correspondent
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
4600 Anson Boulevard
Whitestown,  IN  46075
Correspondent Contact Margo Enright
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   CHH   JGY   LBR  
Date Received12/09/2019
Decision Date 02/26/2022
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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