# Infopia Co, Ltd.

- Location (FDA's records): Great Neck, NY
- FDA decisions: 20 (2005–2016): 20 510(k) clearances
- Product codes: NBW (15), LCP (3), CGA (2)
- Predicates its devices cite: 26 (14 its own); citations of its devices by later devices: 17 (14 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
- Lifescan, Inc.: 3 (https://510kreport.com/company/lifescan)
- Hmd Biomedical, Inc.: 3 (https://510kreport.com/company/hmd-biomedical)
- Polymer Technology Systems, Inc.: 2 (https://510kreport.com/company/polymer-technology-systems)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)
- Healthpia America Corp.: 1 (https://510kreport.com/company/healthpia-america)
- Siemens Medical Solutions Diagnostics: 1 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)

## Firms that cite its devices most
- Osang Healthcare Co., Ltd.: 2 (https://510kreport.com/company/osang-healthcare)
- Hubdic Co., Ltd.: 1 (https://510kreport.com/company/hubdic)

## Its most-cited devices
- K051285: Glucolab Blood Glucose Monitoring System (2005), cited by 4
- K132966: Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring System (2013), cited by 3
- K130181: Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring System (2013), cited by 2
- K103021: Element Plus Blood Glucose Monitoring System (2011), cited by 2
- K090405: Lipidpro System (2009), cited by 1
- K113670: Element Blood Glucose Monitoring System (2012), cited by 1

## Recent decisions
- K160365: BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System (Sep 28, 2016)
- K150274: GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System (Aug 26, 2015)
- K141750: Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System (Jul 24, 2014)
- K132406: Elementv Blood Glucose Monitoring System (Apr 18, 2014)
- K133045: Element TM Lite Blood Glucose Monitoring System (Apr 10, 2014)
- K132862: Healthpro Professional Blood Glucose Monitoring System (Dec 12, 2013)
- K132966: Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring System (Dec 5, 2013)
- K130181: Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring System (Jul 31, 2013)

Source page: https://510kreport.com/company/infopia