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Polymer Technology Systems

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
27
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1438-2020Class IIPTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS DeJanuary 21, 2020
Z-0832-2020Class IIPTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, RefeDecember 2, 2019
Z-0835-2020Class IIHenry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, ReferenDecember 2, 2019
Z-0833-2020Class IIPTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carryingDecember 2, 2019
Z-0834-2020Class IIHenry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036December 2, 2019
Z-2158-2019Class IIIHenry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 PJune 7, 2019
Z-2157-2019Class IIIPTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product UsageJune 7, 2019
Z-1373-2019Class IICHOL+HDL+GLU test strips, REF 2412January 16, 2019
Z-1371-2019Class IILipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414January 16, 2019
Z-1372-2019Class IILipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under HenrJanuary 16, 2019
Z-1543-2018Class IIPTS Panels¿ CHOL+GLU Test Strips (REF 1765)March 14, 2018
Z-0683-2020Class IIA1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062December 2, 2016
Z-0684-2020Class IIWalgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056December 2, 2016
Z-0686-2020Class IICVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059December 2, 2016
Z-0685-2020Class IIReliOn FastA1C Test, Software Version Revision D, REF Number 3055December 2, 2016
Z-0682-2020Class IIA1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024;December 2, 2016
Z-0741-2020Class IIPTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek PMarch 15, 2016
Z-1403-2013Class IIPTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by hApril 4, 2013
Z-1903-2012Class IIPTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creaMay 15, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA HDecember 22, 2016
K151530CardioChek Plus Test SystemJuly 7, 2015
K140068CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEMMay 22, 2015
K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel TOctober 2, 2014
K071593PTS PANELS CHOL+HDL PANEL TEST STRIPSOctober 15, 2007
K071507PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPSSeptember 10, 2007
K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPSJanuary 31, 2007
K060617PTS PANELS HDL CHOLESTEROL TEST STRIPSApril 5, 2006
K041750PTS PANELS CHOL+GLU TEST PANELJuly 23, 2004
K040693PTS PANELS LDL CHOLESTEROL TEST STRIPSJuly 6, 2004
K023558PTS PANELS LIPID PANEL TEST STRIPSNovember 15, 2002
K022898PTS PANELS LIPID PANEL TEST STRIPSSeptember 24, 2002
K022401PTS PANELS MULTI-CHEMISTRY CONTROLSAugust 21, 2002
K014099BIOSCANNER PLUSDecember 21, 2001
K013068BIOSCANNER 2000November 20, 2001
K013203BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPSNovember 16, 2001
K013173BIOSCANNER PLUS; LIPID PANEL TEST STRIPSOctober 22, 2001
K010456BIOSCANNER CREATININE TEST STRIPSJune 20, 2001
K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSJuly 3, 2000
K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSMay 24, 2000