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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 K182781
Device Name PTS Professional Chemistry Kit
Applicant
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
7736 Zionsville Road
Indianapolis,  IN  46268
Applicant Contact Samuel Engelman
Correspondent
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics
7736 Zionsville Road
Indianapolis,  IN  46268
Correspondent Contact Samuel Engelman
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CHH   JGY   LBR   LCP  
Date Received10/01/2018
Decision Date 12/21/2018
Decision Substantially Equivalent - Kit (SESK)
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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