MammaPrint— 510(k) K201902
Substantially EquivalentAgendia, Inc.
FDA 510(k) clearance K201902 for MammaPrint, Substantially Equivalent on 2020-11-05. Applicant: Agendia, Inc.. Device class: 2.
Clearance details
- Applicant
- Agendia, Inc.
- Product code
- Code NYI
- Device class
- Class 2
- Regulation
- 21 CFR 866.6040
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvina, CA, US
Recent devices under product code NYI
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