MammaPrint
K-Number: K201902 · 2020-11-05
ApplicantAgendia, Inc.
Decision Date2020-11-05
Product CodeNYI
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
MammaPrint is a medical device manufactured by Agendia, Inc.. It received FDA 510(k) clearance on 2020-11-05 under approval number K201902. The device is classified under product code NYI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MammaPrint?
MammaPrint is a medical device that received FDA 510(k) clearance on 2020-11-05. It is manufactured by Agendia, Inc.. The 510(k) number is K201902.
When was MammaPrint approved by the FDA?
MammaPrint received FDA 510(k) clearance on 2020-11-05, under approval number K201902.
What company makes MammaPrint?
MammaPrint is manufactured by Agendia, Inc..
What is the FDA product code for MammaPrint?
The FDA product code for MammaPrint is NYI.
Other Devices by Agendia, Inc.
Related Devices (Code: NYI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.