# Nano-Ditech Corporation

- Location (FDA's records): Cranbury, NJ
- FDA decisions: 8 (2005–2026): 8 510(k) clearances
- Names in FDA's records: Nano-Ditech Corporation (6); Nano-Ditech Co. (2)
- Product codes: MMI (3), SCA (1), PSZ (1), GQG (1), LDJ (1), QVF (1)
- Predicates its devices cite: 9 (0 its own); citations of its devices by later devices: 5 (0 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
- ACON Laboratories, Inc.: 5 (https://510kreport.com/company/acon-laboratories)
- Healgen: 1 (https://510kreport.com/company/healgen)
- Bd: 1 (https://510kreport.com/company/bd)
- Spectral Diagnostics, Inc.: 1 (https://510kreport.com/company/spectral-diagnostics)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)

## Firms that cite its devices most
- Abbott Diagnostics Scarborough, Inc.: 1 (https://510kreport.com/company/abbott-diagnostics-scarborough)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Hangzhou Clongene Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-clongene-biotech)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- CorDx, Inc.: 1 (https://510kreport.com/company/cordx)

## Its most-cited devices
- K231187: Nano-Check™ COVID-19 Antigen Test (2024), cited by 4
- K240280: Nano-Check™ RSV Test (2024), cited by 1

## Recent decisions
- K252283: Nano-Check Influenza A+B Test (Jan 15, 2026)
- K243561: Nano-Check Influenza+COVID-19 Dual Test (Jun 17, 2025)
- K240280: Nano-Check™ RSV Test (Jul 30, 2024)
- K231187: Nano-Check™ COVID-19 Antigen Test (Jan 23, 2024)
- K102131: Nano-Check Ami Ctni Cardiac Marker Test (Oct 20, 2010)
- K102441: Nano-Check Ami 2 in 1 Cardiac Marker, CTNL and Myoglobin (Oct 20, 2010)
- K050975: Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB and Myoglobin (Mar 2, 2006)
- K050594: Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & Phencyclidine (May 15, 2005)

Source page: https://510kreport.com/company/nano-ditech