# Home Diagnostics, Inc.

- Location (FDA's records): Fort Lauderdale, FL
- FDA decisions: 22 (1985–2009): 22 510(k) clearances
- Product codes: NBW (10), CGA (9), JJX (2), FMK (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Spectrum Medical Supply, Inc.: 2 (https://510kreport.com/company/spectrum-medical-supply)
- Nova Biomedical Corp.: 1 (https://510kreport.com/company/nova-biomedical)
- Mycare Team, Inc.: 1 (https://510kreport.com/company/mycare-team)
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)
- Bionostics, Inc.: 1 (https://510kreport.com/company/bionostics)
- American Biological Technologies, Inc.: 1 (https://510kreport.com/company/american-biological-technologies)

## Its most-cited devices
- K080641: Trueresult Blood Glucose System E4H01-81 (2008), cited by 3
- K030703: Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips (2003), cited by 2
- K042080: Trackease Smart System Blood Glucose System (2004), cited by 1
- K070593: Trackrecord  Data Management Software (2007), cited by 1

## Recent decisions
- K090495: Truebalance Blood Glucose System (Mar 27, 2009)
- K080641: Trueresult Blood Glucose System E4H01-81 (Aug 19, 2008)
- K080710: TRUE2GO Blood Glucose System, Model F4H01-81 (Aug 13, 2008)
- K070593: Trackrecord  Data Management Software (May 7, 2007)
- K060793: Element Blood Glucose Test System (Jul 25, 2006)
- K051147: Sidekick Blood Glucose Test System (Jul 12, 2005)
- K042080: Trackease Smart System Blood Glucose System (Aug 19, 2004)
- K040670: Modification to Truetrack Smart System Blood Glucose Meter, Test Strips and Glucose Control (Mar 25, 2004)

Source page: https://510kreport.com/company/home-diagnostics