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Modification to Affymetrix GeneChip Microarray Instrumentation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K080995

by Affymetrix, Inc.

Identifiers

510(k) Number
K080995 FDA 510(k)
FDA Product Code
NSU FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.2570 FDA 510(k)
Regulation Number
862.2570 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Modification to Affymetrix GeneChip Microarray Instrumentation System is a laboratory-based diagnostic tool used to analyze genetic material. It consists of the GeneChip 3000Dx scanner with an autoloader, the FS450Dx fluidics station, and GCOSDx software. The system performs hybridization, washing, scanning, and data analysis of GeneChip microarrays.

This modification is intended for use in clinical chemistry laboratories. The device is supplied as a system with multiple components and requires appropriate storage conditions. It has received FDA 510(k) clearance with the product code NSU and is classified as Instrumentation For Clinical Multiplex Test Systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Modification To Affymetrix Genechip Microarray Instrumentation System ..., Modification to Affymetrix Genechip Microarray Instrumentation System ..., PDF Microsoft Word - k080995-jvc.doc - Food and Drug Administration, www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Affymetrix, Inc.

Sources (1)

  • FDA 510(k) K080995 24 fields · synced Sep 22, 2026