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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 K142302
Device Name BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
Applicant
Polymer Technology Systems, Inc.
7736 Zionsville Rd.
Indianapolis,  IN  46268
Applicant Contact Jack Rogers
Correspondent
Polymer Technology Systems, Inc.
7736 Zionsville Rd.
Indianapolis,  IN  46268
Correspondent Contact Jack Rogers
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CHH   JGY   LBR   MRR  
Date Received08/18/2014
Decision Date 10/02/2014
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
Predetermined Change
Control Plan Authorized		 No
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