Atlas FDA

Medical Genetics

77 FDA 510(k) clearances · PMA advisory committee

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◉ Watch Medical Genetics

RecordFirmDate
Shield (P230009/S011)Guardant Health, Inc.2025-12-22
OncoMate® MSI Dx Analysis System (P240026)Promega Corporation2025-11-05
Shield (P230009/S009)Guardant Health, Inc.2025-10-30
therascreen® PIK3CA RGQ PCR Kit (P190001/S002)QIAGEN GmbH2025-10-22
QIAGEN therascreen® FGFR RGQ RT-PCR Kit (P180043/S007)QIAGEN GmbH2025-10-03
Shield (P230009/S008)Guardant Health, Inc.2025-09-23
Idylla CDx MSI Test (P250005)Biocartis Us, Inc.2025-08-15
Shield (P230009/S007)Guardant Health, Inc.2025-07-23
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006/S007)Ventana Medical Systems, Inc.2025-06-20
MI Cancer Seek (P240010/S005)Caris Life Sciences2025-06-18
MI Cancer Seek (P240010/S004)Caris Life Sciences2025-06-09
MI Cancer Seek (P240010/S003)Caris Life Sciences2025-06-04
Shield (P230009/S006)Guardant Health, Inc.2025-04-28
Shield (P230009/S005)Guardant Health, Inc.2025-03-12
MI Cancer Seek (P240010/S001)Caris Life Sciences2025-02-06
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S006)Ventana Medical Systems, Inc.2025-01-08
MI Cancer Seek (P240010/S002)Caris Life Sciences2025-01-07
Shield (P230009/S004)Guardant Health, Inc.2025-01-02
therascreen FGFR RGQ PCR Kit (P180043/S008)QIAGEN GmbH2024-12-06
MI Cancer Seek (P240010)Caris Life Sciences2024-11-05
therascreen FGFR RGQ RT-PCR Kit (P180043/S009)QIAGEN GmbH2024-10-23
Shield (P230009/S002)Guardant Health, Inc.2024-10-18
ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (P200011/S002)Pillar Biosciences2024-09-27
Shield (P230009/S001)Guardant Health, Inc.2024-09-20
Shield (P230009)Guardant Health, Inc.2024-07-26
oncoRevealTM CDx (P200011/S001)Pillar Biosciences2024-04-18
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006/S005)Ventana Medical Systems, Inc.2024-01-26
therascreen FGFR RGQ RT-PCR Kit (P180043/S006)QIAGEN GmbH2023-12-22
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S004)Ventana Medical Systems, Inc.2023-11-08
Abbott RealTime IDH1 (P170041/S007)Abbott Molecular, Inc.2023-10-24
therascreen FGFR RGQ RT-PCR Kit (P180043/S005)QIAGEN GmbH2023-09-15
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S002)Ventana Medical Systems, Inc.2023-08-29
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S001)Ventana Medical Systems, Inc.2023-08-23
Agilent Resolution ctDx FIRST (P210040/S001)Exact Sciences Corporation2023-07-27
therascreen PDGFRA RGQ PCR Kit (P210002)QIAGEN GmbH2023-06-29
therascreen BRAF V600E RGQ PCR Kit (P190026/S001)QIAGEN GmbH2023-06-27
FoundationOne Liquid CDx (P200016/S002)Foundation Medicine, Inc.2023-03-08
RESOLUTION ctDx FIRST (P210040)Exact Sciences Corporation2022-12-12
Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime (P170041/S006)Abbott Molecular, Inc.2022-12-01
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006)Ventana Medical Systems, Inc.2022-11-14
FoundationOne®Liquid CDx (P200016/S001)Foundation Medicine, Inc.2022-09-21
Abbott RealTime IDH1 (P170041/S004)Abbott Molecular, Inc.2022-06-02
Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit (P170005/S004)Abbott Molecular, Inc.2022-04-11
therascreen FGFR RGQ RT-PCR Kit (P180043/S003)QIAGEN GmbH2021-11-16
ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (P200011)Pillar Biosciences2021-07-30
Abbott RealTime IDH1 (P170041/S005)Abbott Molecular, Inc.2021-03-03
Abbott RealTime IDH2 (P170005/S003)Abbott Molecular, Inc.2021-03-03
Abbott RealTime IDH1 (P170041/S003)Abbott Molecular, Inc.2021-01-19
Abbott RealTime IDH2 (P170005/S002)Abbott Molecular, Inc.2021-01-19
FoundationOne Liquid CDx (P200016)Foundation Medicine, Inc.2020-11-06
therascreen FGFR RGQ RT-PCR Kit (P180043/S001)QIAGEN GmbH2020-08-18
therascreen BRAF V600E RGQ PCR Kit (P190026)QIAGEN GmbH2020-04-15
therascreen FGFR RGQ PCR Kit (P180043/S002)QIAGEN GmbH2020-04-03
therascreen PIK3CA RGQ PCR Kit (P190001/S001)QIAGEN GmbH2020-04-03
Abbott RealTime IDH1 Assay (P170041/S002)Abbott Molecular, Inc.2019-11-12
RealTime IDH1 (P170041/S001)Abbott Molecular, Inc.2019-09-24
RealTime IDH2 (P170005/S001)Abbott Molecular, Inc.2019-09-24
therascreen PIK3CA RGQ PCR Kit (P190004)QIAGEN GmbH2019-05-24
therascreen PIK3CA RGQ PCR Kit (P190001)QIAGEN GmbH2019-05-24
therascreen FGFR RGQ RT-PCR Kit (P180043)QIAGEN GmbH2019-04-12
Abbott RealTime IDH1 (P170041)Abbott Molecular, Inc.2018-07-20
Abbott RealTime IDH2 (P170005)Abbott Molecular, Inc.2017-08-01

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Every clearance here is in the API, with alerts when new ones post.