MammaPrint FFPE NGS Kit— 510(k) K210973

Substantially Equivalent

Agendia, Inc.

FDA 510(k) clearance K210973 for MammaPrint FFPE NGS Kit, Substantially Equivalent on 2022-09-08. Applicant: Agendia, Inc..

Clearance details

Applicant: Agendia, Inc.
Product code: Code NYI
Advisory panel: Immunology
Date received: 2021-03-31
Decision date: 2022-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvina, CA, US

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