Atlas FDA

Pathology

1,195 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S010)Foundation Medicine, Inc.2023-06-08
xT CDx (P210011/S001)Tempus AI, Inc.2023-06-07
FoundationOne CDx (P170019/S037)Foundation Medicine, Inc.2023-05-26
VENTANA MMR RxDx Panel (P210001/S008)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2023-05-26
FoundationOne CDx (P170019/S044)Foundation Medicine, Inc.2023-05-26
Guardant360 CDx (P200010/S014)Guardant Health, Inc.2023-05-16
Guardant360 CDx (P200010/S013)Guardant Health, Inc.2023-05-08
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S005)Foundation Medicine, Inc.2023-05-03
xT CDx (P210011)Tempus AI, Inc.2023-04-28
BRACAnalysis CDx (P140020/S027)Myriad Genetic Laboratories2023-04-26
Oncomine Dx Target Test (P160045/S041)Life Technologies Corporation2023-04-07
Cologuard® (P130017/S055)Exact Sciences Corporation2023-03-16
FoundationOne Liquid CDx (F1 Liquid CDx) (P200006/S004)Foundation Medicine, Inc.2023-03-08
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S009)Foundation Medicine, Inc.2023-03-08
VENTANA PD-L1 (SP263) Assay (P160046/S013)Ventana Medical Systems, Inc.2023-03-01
FoundationOne CDx (F1CDx) (P170019/S041)Foundation Medicine, Inc.2023-02-24
Praxis Extended RAS Panel (P160038/S025)Illumina, Inc.2023-02-17
Oncomine Dx Target Test (P160045/S040)Life Technologies Corporation2023-02-10
VENTANA PD-L1 (SP142) Assay (P160002/S020)Ventana Medical Systems, Inc.2023-02-07
LeukoStrat® CDx FL T3 Mutation Assay (P160040/S012)Invivoscribe Technologies, Inc.2023-02-06
Oncomine Dx Target Test (P160045/S038)Life Technologies Corporation2023-02-01
CINtec PLUS Cytology (P190024/S009)Ventana Medical Systems, Inc.2023-01-30
Guardant360 CDx (P200010/S010)Guardant Health, Inc.2023-01-27
BRACAnalysis CDx® (P140020/S026)Myriad Genetic Laboratories2023-01-27
Praxis Extended RAS Panel (P160038/S024)Illumina, Inc.2023-01-13
FoundationOne Liquid CDx (F1LCDx) (P190032/S004)Foundation Medicine, Inc.2022-12-22
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S008)Foundation Medicine, Inc.2022-12-19
therascreen KRAS RGQ PCR Kit (P110027/S013)QIAGEN GmbH2022-12-12
cobas® EGFR Mutation Test (P120019/S033)Roche2022-11-29
cobas® EZH2 Mutation Test (P200014/S004)Roche Molecular System, Inc.2022-11-29
cobas® KRAS Mutation Test (P140023/S024)Roche Molecular Systems, Inc.2022-11-29
cobas® BRAF V600 Mutation Test (P110020/S036)Roche Molecular Systems, Inc.2022-11-29
BRACAnalysis CDx® (P140020/S025)Myriad Genetic Laboratories2022-11-16
cobas® BRAF V600 Mutation Test (P110020/S037)Roche Molecular Systems, Inc.2022-11-14
cobas® KRAS Mutation Test (P140023/S025)Roche Molecular Systems, Inc.2022-11-14
MyChoice CDx® (P190014/S007)Myriad Genetic Laboratories, Inc.2022-11-14
cobas® EGFR Mutation Test, v2.0 (P120019/S034)Roche2022-11-14
VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S006)Ventana Medical Systems2022-11-10
CINtec PLUS Cytology (P190024/S008)Ventana Medical Systems, Inc.2022-11-10
BRACAnalysis CDx® (P140020/S024)Myriad Genetic Laboratories2022-11-10
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S050)Ventana Medical Systems, Inc.2022-11-10
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S028)Ventana Medical Systems, Inc.2022-11-10
VENTANA ALK (D5F3) CDx Assay (P140025/S020)Ventana Medical Systems, Inc.2022-11-10
VENTANA PD-L1 (SP263) Assay (P160046/S015)Ventana Medical Systems, Inc.2022-11-10
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S038)Ventana Medical Systems, Inc.2022-11-10
VENTANA PD-L1 (SP142) Assay (P160002/S019)Ventana Medical Systems, Inc.2022-11-10
VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) (P210001/S007)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2022-11-10
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S007)Ventana Medical Systems, Inc.2022-11-10
PD-L1 IHC 22C3 pharmDx (P150013/S025)Agilent Technologies, Inc.2022-11-03
FoundationOne Liquid CDx (F1 Liquid CDx) (P200006/S003)Foundation Medicine, Inc.2022-10-28
Guardant360 CDx (P200010/S009)Guardant Health, Inc.2022-10-26
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S047)Ventana Medical Systems, Inc.2022-09-30
FoundationOne CDx (FICDx) (P170019/S038)Foundation Medicine, Inc.2022-09-27
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S007)Foundation Medicine, Inc.2022-09-21
FoundationOne®Liquid CDx (P200006/S002)Foundation Medicine, Inc.2022-09-21
FoundationOne®Liquid CDx (P190032/S006)Foundation Medicine, Inc.2022-09-21
Oncomine Dx Target Test (P160045/S031)Life Technologies Corporation2022-09-21
Oncomine Dx Target Test (P160045/S037)Life Technologies Corporation2022-09-19
Praxis Extended RAS Panel (P160038/S023)Illumina, Inc.2022-08-30
Oncomine Dx Target Test (P160045/S036)Life Technologies Corporation2022-08-11
Oncomine Dx Target Test (P160045/S035)Life Technologies Corporation2022-08-11
Guardant360 CDx (P200010/S008)Guardant Health, Inc.2022-08-11
Cologuard® (P130017/S054)Exact Sciences Corporation2022-08-03
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S037)Ventana Medical Systems, Inc.2022-07-29
CINtec PLUS Cytology (P190024/S007)Ventana Medical Systems, Inc.2022-07-29
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S005)Ventana Medical Systems, Inc.2022-07-29
VENTANA ALK (D5F3) CDx Assay (P140025/S018)Ventana Medical Systems, Inc.2022-07-29
Guardant360® CDx (P200010/S011)Guardant Health, Inc.2022-07-29
VENTANA PD-L1 (SP142) Assay (P160002/S018)Ventana Medical Systems, Inc.2022-07-29
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S027)Ventana Medical Systems, Inc.2022-07-29
VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) (P210001/S006)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2022-07-29
VENTANA PD-L1 (SP263) Assay (P160046/S014)Ventana Medical Systems, Inc.2022-07-29
VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S005)Ventana Medical Systems2022-07-29
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S048)Ventana Medical Systems, Inc.2022-07-29
PD-L1 IHC 28-8 pharmDx (P150025/S015)Agilent Technologies, Inc.2022-07-22
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S004)Ventana Medical Systems, Inc.2022-07-21
VENTANA ALK (D5F3) CDx Assay (P140025/S017)Ventana Medical Systems, Inc.2022-07-21
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S036)Ventana Medical Systems, Inc.2022-07-21
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S046)Ventana Medical Systems, Inc.2022-07-21
VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S004)Ventana Medical Systems2022-07-21
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S026)Ventana Medical Systems, Inc.2022-07-21
VENTANA MMR RxDx Panel Solid Tumors with dMMR status) (P210001/S004)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2022-07-21
VENTANA PD-Ll (SP263) Assay (P160046/S012)Ventana Medical Systems, Inc.2022-07-21
CINtec PLUS Cytology (P190024/S006)Ventana Medical Systems, Inc.2022-07-21
VENTANA PD-Ll (SP142) Assay (P160002/S017)Ventana Medical Systems, Inc.2022-07-21
Cologuard® (P130017/S053)Exact Sciences Corporation2022-07-19
therascreen KRAS RGQ PCR Kit (P110027/S015)QIAGEN GmbH2022-07-11
BD FocalPoint GS Imaging System (P950009/S026)Bd Diagnostics2022-07-11
FoundationOne CDx (F1CDx) (P170019/S035)Foundation Medicine, Inc.2022-07-08
Cologuard® (P130017/S052)Exact Sciences Corporation2022-07-07
Praxis Extended RAS Panel (P160038/S022)Illumina, Inc.2022-07-05
Guardant360 CDx (P200010/S006)Guardant Health, Inc.2022-06-27
therascreen KRAS RGQ PCR Kit (P110027/S014)QIAGEN GmbH2022-06-17
VENTANA MMR RxDx Panel (P210001/S002)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2022-06-16
VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S003)Ventana Medical Systems2022-06-10
VENTANA ALK (D5F3) CDx Assay (P140025/S016)Ventana Medical Systems, Inc.2022-06-10
VENTANA MMR RxDx Panel (P210001/S003)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2022-06-10
VENTANA PD-L1 (SP263) Assay (P160046/S011)Ventana Medical Systems, Inc.2022-06-10
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S003)Ventana Medical Systems, Inc.2022-06-10
CINtec PLUS Cytology (P190024/S005)Ventana Medical Systems, Inc.2022-06-10
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