# Bionostics, Inc.

- Location (FDA's records): Devens, MA
- FDA decisions: 49 (1983–2013): 49 510(k) clearances
- Product codes: JJX (22), JJY (10), JJS (5), JJR (2), CHL (2), KRZ (1), DIF (1), JIS (1), LCH (1), JGS (1), GLK (1), OSL (1)
- Predicates its devices cite: 43 (17 its own); citations of its devices by later devices: 32 (17 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
- Roche Diagnostics Corp.: 4 (https://510kreport.com/company/roche-diagnostics)
- Avl Scientific Corp.: 2 (https://510kreport.com/company/avl-scientific)
- Bayer Healthcare, LLC: 2 (https://510kreport.com/company/bayer-healthcare)
- Medical Specialties Supply Co., Inc.: 2 (https://510kreport.com/company/medical-specialties-supply)
- Kaulson Laboratories, Inc.: 1 (https://510kreport.com/company/kaulson-laboratories)
- Waters Instruments, Inc.: 1 (https://510kreport.com/company/waters-instruments)
- Canterbury Scientific, Ltd.: 1 (https://510kreport.com/company/canterbury-scientific)
- Medisense, Inc.: 1 (https://510kreport.com/company/medisense)

## Firms that cite its devices most
- Eurotrol B.V.: 4 (https://510kreport.com/company/eurotrol)
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- Avl Scientific Corp.: 2 (https://510kreport.com/company/avl-scientific)
- Tianjin Empecs Medical Device Co., Ltd.: 1 (https://510kreport.com/company/tianjin-empecs-medical-device)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)
- Diamond Diagnostics, Inc.: 1 (https://510kreport.com/company/diamond-diagnostics)
- Vivachek Laboratories, Inc.: 1 (https://510kreport.com/company/vivachek-laboratories)

## Its most-cited devices
- K880447: Multi-Function Blood Gas Control (1988), cited by 4
- K032453: Roche Combitrol and Autotrol Plus B Multi Analyte Control (2003), cited by 4
- K012430: Multi-Meter Glucose Calibration Verification Material, Model Rna GL3 (2001), cited by 4
- K022769: Lifescan Onetouch Ultra Control Solution (2002), cited by 3
- K955630: Rna Medical Hemat Control (1996), cited by 3
- K002540: Bionostics Glucose Quality Control Solution for Use with Medisense Blood Glucose Test Strip Systems (2000), cited by 2

## Recent decisions
- K131136: Glucose Meter-Check Solution for Taidoc (May 31, 2013)
- K123851: Glucose Meter-Check Solution for Roche Accu-Chek (Feb 14, 2013)
- K123966: Glucose Meter-Check Solution for Bayer (Jan 25, 2013)
- K113764: Glucose Meter-Check Solution for Infopia (Jan 30, 2012)
- K112352: Glucose Meter-Check Control for Nipro Trueresult (Dec 23, 2011)
- K112356: Glucose Meter-Check Control Solution for Agamatrix Wavesense (Sep 19, 2011)
- K103553: Lifescan Onetouch Select / Ultra / Vita Glucose Control Solution (Feb 10, 2011)
- K101831: Enterix Insurefit Fob Controls, Model 16800 (Oct 1, 2010)

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