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510(k) K210973

Device
MammaPrint FFPE NGS Kit
Applicant
Agendia Inc.
510(k) number
K210973
Product code
NYI  
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-08
Date received
2021-03-31
Regulation
866.6040
Classification name
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Medical specialty
Immunology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Marcelo Trevino
Address
22 Morgan Irvina CA US 92618 92618

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NYI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201902MammaPrintAgendia, Inc.2020-11-05
K141142MAMMAPRINT FFPEAgendia2015-01-23
K141771PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAYNanostring Technologies, Inc.2014-11-07
K130010PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAYNanostring Technologies2013-09-06
K101454MAMMAPRINTAgendia2011-01-28
K081092MODIFICATION TO MAMMAPRINTAgendia2009-12-11
K080252MODIFICATION TO MAMMAPRINTAgendia BV2008-07-21
K070675MAMMAPRINTAgendia BV2007-06-22
DEN070009MAMMAPRINTAgendia BV2007-02-06

Legacy Summary#

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FDA Review#

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