# Polymer Technology Systems, Inc. D/B/A Pts Diagnostics

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 3 (2016–2022): 3 510(k) clearances
- Product codes: CGA (2), NBW (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Polymer Technology Systems, Inc.: 5 (https://510kreport.com/company/polymer-technology-systems)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)

## Recent decisions
- K193406: CardioChek Plus Test System; CardioChek Plus Home Test System (Feb 26, 2022)
- K182781: PTS Professional Chemistry Kit (Dec 21, 2018)
- K162282: CardioChek Plus Test System, CardioChek Home Test System (Dec 22, 2016)

Source page: https://510kreport.com/company/polymer-technology-systems-d-b-a-pts-diagnostics