# Apex BioTechnology Corp.

- Location (FDA's records): Hsinchu, TW
- FDA decisions: 35 (2001–2025): 35 510(k) clearances
- Product codes: NBW (18), CGA (14), JIN (1), PTC (1), JJX (1)
- 510(k) review time since 2016: median 228 days, against 410 for FDA's reviews in the same codes and years (8 of 11 faster)
- Predicates its devices cite: 28 (24 its own); citations of its devices by later devices: 28 (24 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nova Biomedical Corp.: 4 (https://510kreport.com/company/nova-biomedical)

## Firms that cite its devices most
- Telcare, Inc.: 2 (https://510kreport.com/company/telcare)
- Eumed Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/eumed-biotechnology)
- Bionostics, Inc.: 1 (https://510kreport.com/company/bionostics)

## Its most-cited devices
- K102037: Autosure Voice II Blood Glucose Monitoring System and Test Strips (2010), cited by 4
- K062799: Gluco Track Blood Glucose Monitoring System (2007), cited by 3
- K113208: Gal-1A Blood Glucose Monitoring System (2012), cited by 3
- K102816: Gal-1C Blood Glucose Monitoring System, Gal-1C Test Strips (2011), cited by 2
- K161299: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System (2016), cited by 2
- K113098: Autosure Voice II Plus, Autosure Plus Blood Glucose Test Strips,Contrex Plus Iii (2012), cited by 2

## Recent decisions
- K242209: UASure II Blood Uric Acid Monitoring System (Apr 4, 2025)
- K222234: GlucoSure ADVANCE Link Blood Glucose Monitoring System (Dec 21, 2022)
- K220421: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System (Nov 4, 2022)
- K212140: GlucoSure Link Blood Glucose Monitoring System (Aug 25, 2022)
- K202534: MTM301 Blood Glucose and Ketone Monitoring System (Apr 6, 2022)
- K213887: GAL-1A Plus Blood Glucose Monitoring System (Mar 29, 2022)
- K201880: MultiSure GK Link Blood Glucose and Ketone Monitoring System (Oct 15, 2021)
- K202885: GlucoSure HT Plus Blood Glucose Monitoring System (Sep 15, 2021)

Source page: https://510kreport.com/company/apex-biotechnology