Affymetrix Inc
FDA Regulatory Profile
Affymetrix Inc appears in FDA public data with 1 recall, 4 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1909-2016, Class III) was initiated on April 14, 2016. Its most recent 510(k) clearance was granted on January 17, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 4
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1909-2016 | Class III | CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a mic | April 14, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN130018 | CYTOSCAN(R) DX | January 17, 2014 |
| K103112 | AFFYMETRIX GENE PROFILING REAGENTS | May 4, 2011 |
| K080995 | MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | July 30, 2008 |
| DEN040012 | AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM | December 23, 2004 |