MODIFICATION TO MAMMAPRINT
FDA 510(k) clearance K081092 · decided 2009-12-11
Clearance details
- K-number
- K081092
- Device name
- MODIFICATION TO MAMMAPRINT
- Applicant
- Agendia
- Decision
- Substantially Equivalent
- Date received
- 2008-04-17
- Decision date
- 2009-12-11
- Days to decision
- 603 days
- Clearance type
- Traditional
- Product code
- NYI
- Device class
- 2
- Regulation number
- 866.6040
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Amsterdam, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MammaPrint FFPE NGS Kit (K210973) | Agendia, Inc. | 2022-09-08 |
| MammaPrint (K201902) | Agendia, Inc. | 2020-11-05 |
| MAMMAPRINT FFPE (K141142) | Agendia | 2015-01-23 |
| PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K141771) | Nanostring Technologies, Inc. | 2014-11-07 |
| PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (K130010) | Nanostring Technologies | 2013-09-06 |
| MAMMAPRINT (K101454) | Agendia | 2011-01-28 |
| MODIFICATION TO MAMMAPRINT (K080252) | Agendia BV | 2008-07-21 |
| MAMMAPRINT (K070675) | Agendia BV | 2007-06-22 |
| MAMMAPRINT (DEN070009) | Agendia BV | 2007-02-06 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Agendia MammaPrint, Catalog Numbers MP01, MP US version 03 recall (Z-1321-2010) | Agendia Inc | 2010-04-12 |