# Sd Biosensor

- Location (FDA's records): Suwon-Si, KR
- FDA decisions: 6 (2014–2017): 6 510(k) clearances
- Names in FDA's records: Sd Biosensor (4); Sd Biosensor, Inc. (2)
- Product codes: NBW (5), LCP (1)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Standard Diagnostics, Inc.: 3 (https://510kreport.com/company/standard-diagnostics)
- Polymer Technology Systems, Inc.: 2 (https://510kreport.com/company/polymer-technology-systems)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)
- Axis-Shield Poc AS: 1 (https://510kreport.com/company/axis-shield-poc)

## Its most-cited devices
- K132929: SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System (2015), cited by 1
- K123517: Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System (2014), cited by 1

## Recent decisions
- K160282: SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (Oct 17, 2017)
- K153201: SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System (Jun 24, 2016)
- K151265: SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System (Nov 24, 2015)
- K140827: SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set (Sep 30, 2015)
- K132929: SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System (Aug 5, 2015)
- K123517: Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System (Jan 17, 2014)

Source page: https://510kreport.com/company/sd-biosensor