MammaPrint FFPE NGS Kit
K-Number: K210973 · 2022-09-08
ApplicantAgendia, Inc.
Decision Date2022-09-08
Product CodeNYI
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
MammaPrint FFPE NGS Kit is a medical device manufactured by Agendia, Inc.. It received FDA 510(k) clearance on 2022-09-08 under approval number K210973. 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 FFPE NGS Kit?
MammaPrint FFPE NGS Kit is a medical device that received FDA 510(k) clearance on 2022-09-08. It is manufactured by Agendia, Inc.. The 510(k) number is K210973.
When was MammaPrint FFPE NGS Kit approved by the FDA?
MammaPrint FFPE NGS Kit received FDA 510(k) clearance on 2022-09-08, under approval number K210973.
What company makes MammaPrint FFPE NGS Kit?
MammaPrint FFPE NGS Kit is manufactured by Agendia, Inc..
What is the FDA product code for MammaPrint FFPE NGS Kit?
The FDA product code for MammaPrint FFPE NGS Kit 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.