FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MammaPrint
K Number: K201902
·
Decision Nov 5, 2020
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
2
Review Days
120
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Basic Information
- Device Name
- MammaPrint
- K Number
- K201902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agendia, Inc.
- Date Received
- July 8, 2020
- Decision Date
- November 5, 2020
- Product Code
- NYI
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NYI | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NYI), ordered by most recent decision date.
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PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
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MODIFICATION TO MAMMAPRINT
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Agendia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | Sep 8, 2022 | Substantially Equivalent |