# Chemtex USA, Inc.

- Location (FDA's records): Fairfield, NJ
- FDA decisions: 2 (2020–2022): 2 510(k) clearances
- Product codes: LPN (2)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 1 (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
- Optics Laboratory, Inc.: 1 (https://510kreport.com/company/optics-laboratory)
- Purilens, Inc.: 1 (https://510kreport.com/company/purilens)
- The Lifestyle Co., Inc.: 1 (https://510kreport.com/company/lifestyle)
- Menicon Co, Ltd.: 1 (https://510kreport.com/company/menicon)
- Dry Eye Innovations, LLC: 1 (https://510kreport.com/company/dry-eye-innovations)

## Its most-cited devices
- K193441: Aqua Naina Sterile Saline Solution (2020), cited by 1

## Recent decisions
- K221263: Aqua Naina Plus Sterile Saline Solution (Oct 12, 2022)
- K193441: Aqua Naina Sterile Saline Solution (May 26, 2020)

Source page: https://510kreport.com/company/chemtex-usa