Agendia BV
Agendia BV appears in FDA public data with 0 recalls, 8 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 8, 2022.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | September 8, 2022 |
| K201902 | MammaPrint | November 5, 2020 |
| K141142 | MAMMAPRINT FFPE | January 23, 2015 |
| K101454 | MAMMAPRINT | January 28, 2011 |
| K081092 | MODIFICATION TO MAMMAPRINT | December 11, 2009 |
| K080252 | MODIFICATION TO MAMMAPRINT | July 21, 2008 |
| K070675 | MAMMAPRINT | June 22, 2007 |
| DEN070009 | MAMMAPRINT | February 6, 2007 |