# Polymer Technology Systems, Inc.

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 27 (1998–2016): 27 510(k) clearances
- Product codes: CHH (7), NBW (6), CGA (4), NAQ (2), JGY (2), JMK (2), JJY (1), JFY (1), LBR (1), MRR (1)
- Predicates its devices cite: 40 (34 its own); citations of its devices by later devices: 45 (34 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boehringer Mannheim Corp.: 3 (https://510kreport.com/company/boehringer-mannheim)
- Maine Standards Co.: 2 (https://510kreport.com/company/maine-standards)
- Sigma Diagnostics, Inc.: 1 (https://510kreport.com/company/sigma-diagnostics)

## Firms that cite its devices most
- Polymer Technology Systems, Inc. D/B/A Pts Diagnostics: 5 (https://510kreport.com/company/polymer-technology-systems-d-b-a-pts-diagnostics)
- Infopia Co, Ltd.: 2 (https://510kreport.com/company/infopia)
- Sd Biosensor: 2 (https://510kreport.com/company/sd-biosensor)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Biomedix, Inc.: 1 (https://510kreport.com/company/biomedix)

## Its most-cited devices
- K140068: Cardiochek Plus Test System, Cardiochek Home Test System (2015), cited by 5
- K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220 (1998), cited by 4
- K023558: PTS Panels Lipid Panel Test Strips (2002), cited by 4
- K013068: Bioscanner 2000 (2001), cited by 3
- K990688: MTM Bioscanner C Test Strips (1999), cited by 3
- K972669: MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner G Test Strip, Norman Glucose Con (1998), cited by 3

## Recent decisions
- K151545: CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (Dec 22, 2016)
- K151530: CardioChek Plus Test System (Jul 7, 2015)
- K140068: Cardiochek Plus Test System, Cardiochek Home Test System (May 22, 2015)
- 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 (Oct 2, 2014)
- K071593: PTS Panels Chol+HDL Panel Test Strips (Oct 15, 2007)
- K071507: PTS Panels Chol+HDL+Glu Panel Test Strips (Sep 10, 2007)
- K070017: PTS Panels Metabolic Chemistry Panel Test Strips (Jan 31, 2007)
- K060617: PTS Panels HDL Cholesterol Test Strips (Apr 5, 2006)

Source page: https://510kreport.com/company/polymer-technology-systems