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Polymer Technology Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155251483002698769Polymer Technology Systems1N2026-01-014600 Anson Boulevard Whitestown IN US 46075

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2301272004244853K993096PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITORCHH1999-12-20
2301271285450771K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSJGY2000-05-24
2301271427364015K990688MTM BIOSCANNER C TEST STRIPSCHH1999-06-24
2301271625811542K983860MTM BIOSCANNER K TEST STRIPS, CAT # BSA610JMK1999-12-27
2301271481318122K981865MTM BIOSCANNER K TEST STRIPSJMK1999-02-26
2301271094868855K981493MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220CHH1998-07-22
2301271707722418K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemNBW2022-02-26
2301271182118671K182781PTS Professional Chemistry KitCGA2018-12-21
2301271648177097K162282CardioChek Plus Test System, CardioChek Home Test SystemCGA2016-12-22
2301271039697893K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemCHH2016-12-22
2301271969326083K151530CardioChek Plus Test SystemCGA2015-07-07
2301271276139235K142302BioScanner 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 SystemCGA2014-10-02
2301271918255599K140068CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEMNBW2015-05-22
2301271312347491K103744DROPPER A1C DIABETES CONTROLJJX2011-05-12
2301271139366308K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHECLCP2009-05-14
2301271336852717K071593PTS PANELS CHOL+HDL PANEL TEST STRIPSCHH2007-10-15
2301271691547492K071507PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPSNBW2007-09-10
2301271741323664K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPSNBW2007-01-31
2301271439224948K060617PTS PANELS HDL CHOLESTEROL TEST STRIPSNAQ2006-04-05
2301271712469498K041750PTS PANELS CHOL+GLU TEST PANELNBW2004-07-23
2301271700899063K040693PTS PANELS LDL CHOLESTEROL TEST STRIPSMRR2004-07-06
2301271941484892K033899LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITORNFX2004-05-20
2301271606525611K023558PTS PANELS LIPID PANEL TEST STRIPSCHH2002-11-15
2301271165628272K022898PTS PANELS LIPID PANEL TEST STRIPSCHH2002-09-24
2301271377122529K022401PTS PANELS MULTI-CHEMISTRY CONTROLSJJY2002-08-21
2301271461113482K014099BIOSCANNER PLUSNBW2001-12-21
2301271083111825K013068BIOSCANNER 2000CGA2001-11-20
2301271104304077K010456BIOSCANNER CREATININE TEST STRIPSJFY2001-06-20
2301271105606720K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSJGY2000-07-03
2301271000627514
2301271293161840
2301271904219936
2301271959102952

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CHH82016-12-22
NBW62022-02-26
CGA52018-12-21
JGY22000-07-03
JMK21999-12-27
JJX12011-05-12
LCP12009-05-14
NAQ12006-04-05
MRR12004-07-06
NFX12004-05-20
JJY12002-08-21
JFY12001-06-20