# Agamatrix, Inc.

- Location (FDA's records): Salem, NH
- FDA decisions: 14 (2006–2024): 14 510(k) clearances
- Names in FDA's records: Agamatrix, Inc. (7); Agamatrix (7)
- Product codes: NBW (14)
- 510(k) review time since 2016: median 148 days, against 233 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 10 (9 its own); citations of its devices by later devices: 15 (9 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
- Abbott Diabetes Care, Inc.: 1 (https://510kreport.com/company/abbott-diabetes-care)

## Firms that cite its devices most
- American Biological Technologies, Inc.: 1 (https://510kreport.com/company/american-biological-technologies)
- Liberty Healthcare Group, Inc.: 1 (https://510kreport.com/company/liberty-healthcare-group)
- Bionostics, Inc.: 1 (https://510kreport.com/company/bionostics)
- Philosys, Inc.: 1 (https://510kreport.com/company/philosys)
- Samsung Electronics Co., Ltd.: 1 (https://510kreport.com/company/samsung-electronics)
- I-Sens, Inc.: 1 (https://510kreport.com/company/i-sens)

## Its most-cited devices
- K052762: Liberty Blood Glucose Monitoring System, Model 8000-0067 (2006), cited by 4
- K103544: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D (2011), cited by 3
- K062434: Zero-Click Data Management System, Model 8000-01528 (2006), cited by 2
- K101597: Wavesense Diabetes Manager Model Version 1.3.4 (2010), cited by 2
- K152365: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (2016), cited by 1
- K072413: Modification to: Jazz Blood Glucose Monitoring System (2007), cited by 1

## Recent decisions
- K241304: WaveSense Jazz Blood Glucose Monitoring System (Jun 6, 2024)
- K161834: One Drop Blood Glucose Monitoring System (Nov 30, 2016)
- K152365: AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (Apr 21, 2016)
- K132821: Agamatrix Health Manager (Nov 20, 2013)
- K130535: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application (Apr 17, 2013)
- K103544: Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev D (Dec 7, 2011)
- K101597: Wavesense Diabetes Manager Model Version 1.3.4 (Oct 18, 2010)
- K083265: Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381 (Feb 3, 2009)

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