# Standard Diagnostics, Inc.

- Location (FDA's records): Great Neck, NY
- FDA decisions: 3 (2003–2010): 3 510(k) clearances
- Product codes: NBW (2), LCX (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 5 (1 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
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)

## Firms that cite its devices most
- Sd Biosensor: 3 (https://510kreport.com/company/sd-biosensor)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)

## Its most-cited devices
- K100398: Smartlink Gold Blood Glucose Monitoring System (2010), cited by 3
- K031798: Good Morning Test (2003), cited by 1
- K082683: SD Check Gold (2009), cited by 1

## Recent decisions
- K100398: Smartlink Gold Blood Glucose Monitoring System (Jun 9, 2010)
- K082683: SD Check Gold (Dec 8, 2009)
- K031798: Good Morning Test (Nov 12, 2003)

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