Company ยท US
Affymetrix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2014. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 2014 | DEN130018 | CYTOSCAN(R) DX Affymetrix, Inc. | PFX |
| May 4, 2011 | K103112 | AFFYMETRIX GENE PROFILING REAGENTS Affymetrix, Inc. | OVA |
| Jul 30, 2008 | K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. | NSU |
| Dec 23, 2004 | DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. | NSU |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 14, 2016 | Affymetrix Inc CytoScan Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software.
The CytoScan Dx Assay consists of five reagent modules, wash buff Terminated |
PFX | None listed |
| May 6, 2006 | Affymetrix, Inc. Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software Terminated |
NSU | None listed |