# K080995: Modification to Affymetrix Genechip Microarray Instrumentation System

- Pathway: 510(k) (Traditional)
- Applicant: Affymetrix, Inc.
- Decided: Jul 30, 2008 after 114 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103112: Affymetrix Gene Profiling Reagents (2011), 0 descendants of its own

## Indications for use
The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS45ODx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.

Source page: https://510kreport.com/device/K080995
Methodology: https://510kreport.com/methodology