Polymer Technology Systems, Inc.
Polymer Technology Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2016, with 14 FDA device recalls on record.
Top product codes for Polymer Technology Systems, Inc.
FDA recalls by Polymer Technology Systems, Inc.
10 most recent of 14- Z-1438-2020 — PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
- Z-0833-2020 — PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
- Z-0835-2020 — Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
- Z-0834-2020 — Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
- Z-0832-2020 — PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
- Z-2157-2019 — PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.
- Z-2158-2019 — Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.
- Z-1371-2019 — Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
- Z-1373-2019 — CHOL+HDL+GLU test strips, REF 2412
- Z-1372-2019 — Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Polymer Technology Systems, Inc.
- K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
- K151530 — CardioChek Plus Test System
- K140068 — CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
- K142302 — 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
- K071593 — PTS PANELS CHOL+HDL PANEL TEST STRIPS
- K071507 — PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
- K070017 — PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
- K060617 — PTS PANELS HDL CHOLESTEROL TEST STRIPS
- K041750 — PTS PANELS CHOL+GLU TEST PANEL
- K040693 — PTS PANELS LDL CHOLESTEROL TEST STRIPS
- K023558 — PTS PANELS LIPID PANEL TEST STRIPS
- K022898 — PTS PANELS LIPID PANEL TEST STRIPS
- K022401 — PTS PANELS MULTI-CHEMISTRY CONTROLS
- K014099 — BIOSCANNER PLUS
- K013068 — BIOSCANNER 2000
- K013203 — BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
- K013173 — BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
- K010456 — BIOSCANNER CREATININE TEST STRIPS
- K000586 — BIOSCANNER TRIGLYCERIDES TEST STRIPS
- K991894 — BIOSCANNER TRIGLYCERIDES TEST STRIPS
- K993377 — MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
- K983860 — MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
- K990688 — MTM BIOSCANNER C TEST STRIPS
- K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
- K981865 — MTM BIOSCANNER K TEST STRIPS
- K981493 — MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
- K972669 — MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON
Data sourced from openFDA. This site is unofficial and independent of the FDA.