Data / Medical devices / United States / Affymetrix, Inc.
Affymetrix, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 2 510(k) clearances
Affymetrix, Inc. is registered with the FDA (registration 3003314809) in Pleasanton, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 17, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003314809
- Address
- 6055 Sunol Blvd, Pleasanton, CA, United States, 94566
- Owner or operator
- Life Technologies (9066102)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- Concerto Imager, CytoScan® Dx Assay, GeneChip System 3000Dx v.2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection | PFX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 17, 2014 | DEN130018 | CYTOSCAN(R) DX | PFX | Unknown | Affymetrix, Inc. | accessdata.fda.gov |
| December 23, 2004 | DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | NSU | Unknown | Affymetrix, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 26, 2005 | 35175 | Not yet classified | Terminated | Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software | Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
- All makers of Instrumentation For Clinical Multiplex Test Systems
Updated January 17, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.