FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MAMMAPRINT
K Number: K101454
·
Decision Jan 28, 2011
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
3
Review Days
248
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Basic Information
- Device Name
- MAMMAPRINT
- K Number
- K101454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agendia
- Date Received
- May 25, 2010
- Decision Date
- January 28, 2011
- 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 |
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