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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 15 Results
ProductCode: CHH Applicant: POLYMER TECHNOLOGY SYSTEMS, INC. Decision Date To: 05/17/2024
 
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cardiochek plus test system; cardiochek plus home test system Polymer Technology Systems, Inc. d/b/a PTS Diagnostics K193406 02/26/2022
pts professional chemistry kit Polymer Technology Systems, Inc. d/b/a PTS Diagnostics K182781 12/21/2018
cardiochek plus test system, cardiochek home test system Polymer Technology Systems, Inc. d/b/a PTS Diagnostics K162282 12/22/2016
cardiochek plus test system, cardiochek home test system, cardiochek pa test system, cardiochek pa home test system POLYMER TECHNOLOGY SYSTEMS, INC. K151545 12/22/2016
cardiochek plus test system POLYMER TECHNOLOGY SYSTEMS, INC. K151530 07/07/2015
cardiochek plus test system, cardiochek home test system POLYMER TECHNOLOGY SYSTEMS, INC. K140068 05/22/2015
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 Polymer Technology Systems, Inc. K142302 10/02/2014
pts panels chol+hdl panel test strips POLYMER TECHNOLOGY SYSTEMS, INC. K071593 10/15/2007
pts panels chol+hdl+glu panel test strips POLYMER TECHNOLOGY SYSTEMS, INC. K071507 09/10/2007
pts panels chol+glu test panel POLYMER TECHNOLOGY SYSTEMS, INC. K041750 07/23/2004
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