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Agendia

FDA Regulatory Profile

Agendia has 0 FDA recalls, 4 inspections, 8 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 29, 2024 · VAI
Latest 510(k)
Sep 8, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances8Oct 4, 2026Not statedCurrent
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 29, 2024Irvine, CADevicesVoluntary Action Indicated (VAI)3007297853
Apr 12, 2022Irvine, CADevicesNo Action Indicated (NAI)3007297853
Aug 22, 2017Irvine, CADevicesVoluntary Action Indicated (VAI)3007297853
Aug 12, 2011Irvine, CADevicesVoluntary Action Indicated (VAI)3007297853

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K210973MammaPrint FFPE NGS KitSep 8, 2022
K201902MammaPrintNov 5, 2020
K141142MAMMAPRINT FFPEJan 23, 2015
K101454MAMMAPRINTJan 28, 2011
K081092MODIFICATION TO MAMMAPRINTDec 11, 2009
K080252MODIFICATION TO MAMMAPRINTJul 21, 2008
K070675MAMMAPRINTJun 22, 2007
DEN070009MAMMAPRINTFeb 6, 2007

FDA data resources