# Affymetrix, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 3 (2008–2014): 2 510(k) clearances and 1 De Novo grant
- Product codes: PFX (1), NSU (1), OVA (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 2 (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 that cite its devices most
- Agilent Technologies, Inc.: 1 (https://510kreport.com/company/agilent-technologies)

## Its most-cited devices
- DEN130018: Cytoscan (R) DX (2014), cited by 1
- K080995: Modification to Affymetrix Genechip Microarray Instrumentation System (2008), cited by 1

## Recent decisions
- DEN130018: Cytoscan (R) DX (Jan 17, 2014)
- K103112: Affymetrix Gene Profiling Reagents (May 4, 2011)
- K080995: Modification to Affymetrix Genechip Microarray Instrumentation System (Jul 30, 2008)

Source page: https://510kreport.com/company/affymetrix