# Nanoentek USA, Inc.

- Location (FDA's records): Pleasanton, CA
- FDA decisions: 5 (2014–2017): 5 510(k) clearances
- Product codes: LTJ (1), CEC (1), MRG (1), CDZ (1), JLW (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (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
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Nanoentek, Inc.: 1 (https://510kreport.com/company/nanoentek)
- Biokit, S.A.: 1 (https://510kreport.com/company/biokit)
- Tosoh Medics, Inc.: 1 (https://510kreport.com/company/tosoh-medics)

## Recent decisions
- K162378: FREND PSA PLUS (reagent cartridge) (May 17, 2017)
- K162754: FREND Vitamin D Test System (Jan 12, 2017)
- K153577: FREND Testosterone Test System (Oct 14, 2016)
- K152422: FREND™ Free T4 Test System (Feb 17, 2016)
- K131928: Frend TSH (Reagent Cartridge) (Mar 14, 2014)

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