510(k) K081092
- Device
- MODIFICATION TO MAMMAPRINT
- Applicant
- AGENDIA
- 510(k) number
- K081092
- Product code
- NYI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-12-11
- Date received
- 2008-04-17
- Regulation
- 866.6040
- Classification name
- Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
- Medical specialty
- Immunology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Guido Brink
- Address
- Kruislaan 406 Amsterdam NL 1098SM 1098SM
FDA Registration Numbers#
- 3007297853
- 3017845262
- 3039487170
- 2032839
Source Documents#
Other 510(k) Records For Product Code NYI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | 2022-09-08 |
| K201902 | MammaPrint | Agendia, Inc. | 2020-11-05 |
| K141142 | MAMMAPRINT FFPE | Agendia | 2015-01-23 |
| K141771 | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies, Inc. | 2014-11-07 |
| K130010 | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies | 2013-09-06 |
| K101454 | MAMMAPRINT | Agendia | 2011-01-28 |
| K080252 | MODIFICATION TO MAMMAPRINT | Agendia BV | 2008-07-21 |
| K070675 | MAMMAPRINT | Agendia BV | 2007-06-22 |
| DEN070009 | MAMMAPRINT | Agendia BV | 2007-02-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary