FDA Product Code
FDA Product Code NYI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6040
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | 2022-09-08 | Traditional | PDF ↗ |
| K201902 | MammaPrint | Agendia, Inc. | 2020-11-05 | Traditional | PDF ↗ |
| K141142 | MAMMAPRINT FFPE | Agendia | 2015-01-23 | Traditional | PDF ↗ |
| K141771 | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies, Inc. | 2014-11-07 | Traditional | PDF ↗ |
| K130010 | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies | 2013-09-06 | Traditional | PDF ↗ |
| K101454 | MAMMAPRINT | Agendia | 2011-01-28 | Traditional | PDF ↗ |
| K081092 | MODIFICATION TO MAMMAPRINT | Agendia | 2009-12-11 | Traditional | PDF ↗ |
| K080252 | MODIFICATION TO MAMMAPRINT | Agendia BV | 2008-07-21 | Traditional | PDF ↗ |
| K070675 | MAMMAPRINT | Agendia BV | 2007-06-22 | Traditional | PDF ↗ |
| DEN070009 | MAMMAPRINT | Agendia BV | 2007-02-06 | Post-NSE | — |
Product code NYI · Class II · Immunology. Data: openFDA.