Atlas FDA

Pathology

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

Sort:Newest firstOldest first

◉ Watch Pathology

RecordFirmDate
FoundationOne®CDx (F1CDx) (P170019/S052)Foundation Medicine, Inc.2024-08-30
MyChoice CDx (P190014/S009)Myriad Genetic Laboratories, Inc.2024-08-29
ColoSense (P230001/S001)Geneoscopy, Inc.2024-08-23
TruSight Oncology Comprehensive (P230011)Illumina, Inc.2024-08-21
ColoSense (P230001/S002)Geneoscopy, Inc.2024-08-08
Cologuard (P130017/S059)Exact Sciences Corporation2024-08-05
MAGE-A4 IHC 1F9 pharmDx (P230016)Agilent Technologies, Inc.2024-08-01
FoundationOne Liquid CDx (F1LCDx) (P190032/S017)Foundation Medicine, Inc.2024-08-01
COLOGUARD (P130017/S057)Exact Sciences Corporation2024-07-20
Oncomine Dx Target Test (P160045/S048)Life Technologies Corporation2024-07-02
FoundationOne Liquid CDx (F1LCDx) (P190032/S014)Foundation Medicine, Inc.2024-06-28
Guardant360 CDx (P200010/S020)Guardant Health, Inc.2024-06-21
therascreen® KRAS RGQ PCR Kit (P110027/S017)QIAGEN GmbH2024-06-21
Oncomine Dx Target Test (P160045/S045)Life Technologies Corporation2024-06-17
Oncomine Dx Target Test (P160045/S047)Life Technologies Corporation2024-06-13
Guardant360 CDx (P200010/S019)Guardant Health, Inc.2024-06-11
FoundationOne Liquid CDx (F1LCDx) (P190032/S022)Foundation Medicine, Inc.2024-06-03
FoundationOne CDx (F1CDx) (P170019/S053)Foundation Medicine, Inc.2024-06-03
FoundationOne Liquid CDx (P190032/S021)Foundation Medicine, Inc.2024-05-17
Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit (P140023/S030)Roche Molecular Systems, Inc.2024-05-15
ColoSense® (P230001)Geneoscopy, Inc.2024-05-03
FoundationOne CDx (P170019/S045)Foundation Medicine, Inc.2024-04-25
FoundationOne®Liquid CDx (F1LCDx) (P190032/S020)Foundation Medicine, Inc.2024-04-16
Roche cobas 4800 BRAF V600 Mutation Test (P110020/S042)Roche Molecular Systems, Inc.2024-04-11
Roche cobas DNA Sample Preparation Kit (P140023/S029)Roche Molecular Systems, Inc.2024-04-11
VENTANA PD-L1(SP142) Assay (P160002/S024)Ventana Medical Systems, Inc.2024-04-01
Guardant360 CDx (P200010/S016)Guardant Health, Inc.2024-03-18
Guardant360 CDx (P200010/S018)Guardant Health, Inc.2024-03-06
FoundationOne Liquid CDx (F1LCDx) (P190032/S018)Foundation Medicine, Inc.2024-02-08
VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S009)Ventana Medical Systems2024-01-26
VENTANA ALK (D5F3) CDx Assay (P140025/S023)Ventana Medical Systems, Inc.2024-01-26
CINtec PLUS Cytology (P190024/S012)Ventana Medical Systems, Inc.2024-01-26
VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) (P210001/S011)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2024-01-26
VENTANA PD-Ll (SP263) Assay (P160046/S018)Ventana Medical Systems, Inc.2024-01-26
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S053)Ventana Medical Systems, Inc.2024-01-26
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S010)Ventana Medical Systems, Inc.2024-01-26
VENTANA PD-Ll (SP142) Assay (P160002/S023)Ventana Medical Systems, Inc.2024-01-26
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S031)Ventana Medical Systems, Inc.2024-01-26
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S041)Ventana Medical Systems, Inc.2024-01-26
Bond™ Oracle™ HER2 IHC System (P090015/S013)Leica Biosystems2024-01-17
FoundationOne CDx (F1CDx) (P170019/S051)Foundation Medicine, Inc.2024-01-12
Guardant360 CDx (P200010/S017)Guardant Health, Inc.2024-01-11
BD PrepMate (P970018/S040)Bd Diagnostic Systems2023-12-28
Roche cobas EFGR Mutation Test, v2.0 (P120019/S038)Roche2023-12-21
Roche cobas KRAS Mutation Test (P140023/S028)Roche Molecular Systems, Inc.2023-12-21
Roche cobas® EZH2 Mutation Test (P200014/S008)Roche Molecular System, Inc.2023-12-21
Roche cobas BRAF V600 Mutation Test (P110020/S041)Roche Molecular Systems, Inc.2023-12-21
cobas® KRAS Mutation Test (P140023/S027)Roche Molecular Systems, Inc.2023-12-14
cobas® BRAF V600 Mutation Test (P110020/S040)Roche Molecular Systems, Inc.2023-12-14
cobas® EZH2 Mutation Test (P200014/S007)Roche Molecular System, Inc.2023-12-14
cobas® EGFR Mutation Test, v2.0 (P120019/S037)Roche2023-12-14
FoundationOne CDx (F1CDx) (P170019/S050)Foundation Medicine, Inc.2023-12-01
FoundationOne CDx (F1CDx) (P170019/S048)Foundation Medicine, Inc.2023-11-16
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S052)Ventana Medical Systems, Inc.2023-11-08
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S009)Ventana Medical Systems, Inc.2023-11-08
VENTANA PD-Ll (SP142) Assay (P160002/S022)Ventana Medical Systems, Inc.2023-11-08
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S040)Ventana Medical Systems, Inc.2023-11-08
VENTANA PD-Ll (SP263) Assay (P160046/S017)Ventana Medical Systems, Inc.2023-11-08
VENTANA ALK (D5F3) CDx Assay (P140025/S022)Ventana Medical Systems, Inc.2023-11-08
VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM (P210001/S010)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2023-11-08
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S030)Ventana Medical Systems, Inc.2023-11-08
VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM (P200019/S008)Ventana Medical Systems2023-11-08
CINtec PLUS Cytology (P190024/S011)Ventana Medical Systems, Inc.2023-11-08
PD-L1 IHC 22C3 pharmDx (P150013/S027)Agilent Technologies, Inc.2023-11-07
FoundationOne CDx (F1CDx) (P170019/S049)Foundation Medicine, Inc.2023-11-02
Oncomine Dx Target Test (P160045/S044)Life Technologies Corporation2023-11-02
MyChoice® CDx (P190014/S008)Myriad Genetic Laboratories, Inc.2023-10-27
FoundationOne CDx, F1CDx (P170019/S039)Foundation Medicine, Inc.2023-10-11
FoundationOne Liquid CDx (F1LCDx) (P190032/S011)Foundation Medicine, Inc.2023-10-11
FoundationOne CDx (F1CDx) (P170019/S043)Foundation Medicine, Inc.2023-10-06
QIAGEN therascreen® KRAS RGQ PCR Kit (P110027/S016)QIAGEN GmbH2023-10-06
Cologuard® (P130017/S056)Exact Sciences Corporation2023-10-05
Oncomine Dx Target Test (P160045/S025)Life Technologies Corporation2023-09-29
CRCDx RAS Mutation Detection Assay Kit (P220005)Entrogen, Inc.2023-09-29
FoundationOne CDx (F1CDx) (P170019/S036)Foundation Medicine, Inc.2023-09-18
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S008)Ventana Medical Systems, Inc.2023-08-29
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S039)Ventana Medical Systems, Inc.2023-08-29
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S051)Ventana Medical Systems, Inc.2023-08-29
VENTANA PD-Ll (SP263) Assay (P160046/S016)Ventana Medical Systems, Inc.2023-08-29
VENTANA MMR RxDx Panel Solid Tumors with dMMR status) (P210001/S009)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2023-08-29
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S029)Ventana Medical Systems, Inc.2023-08-29
VENTANA ALK (D5F3) CDx Assay (P140025/S021)Ventana Medical Systems, Inc.2023-08-29
VENTANA PD-Ll (SP142) Assay (P160002/S021)Ventana Medical Systems, Inc.2023-08-29
CINtec PLUS Cytology (P190024/S010)Ventana Medical Systems, Inc.2023-08-29
VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S007)Ventana Medical Systems2023-08-29
cobas® EGFR Mutation Test (P120019/S036)Roche2023-08-23
cobas® EZH2 Mutation Test (P200014/S006)Roche Molecular System, Inc.2023-08-23
cobas® 4800 BRAF V600 Mutation Test (P110020/S039)Roche Molecular Systems, Inc.2023-08-23
Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test (P110020/S038)Roche Molecular Systems, Inc.2023-08-17
Oncomine Dx Target Test (P160045/S042)Life Technologies Corporation2023-08-17
Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD (P120019/S035)Roche2023-08-17
cobas® EZH2 Mutation Test (P200014/S005)Roche Molecular System, Inc.2023-08-17
Roche cobas® KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit (P140023/S026)Roche Molecular Systems, Inc.2023-08-17
FoundationOne CDx (F1CDx) (P170019/S042)Foundation Medicine, Inc.2023-08-11
FoundationOne CDx (P170019/S046)Foundation Medicine, Inc.2023-08-10
Oncomine Dx Target Test (P160045/S043)Life Technologies Corporation2023-08-10
LeukoStrat CDx FLT3 Mutation Assay (P160040/S011)Invivoscribe Technologies, Inc.2023-07-20
FoundationOne CDx (F1CDx) (P170019/S040)Foundation Medicine, Inc.2023-07-20
PD-L1 IHC 22C3 pharmDx (P150013/S026)Agilent Technologies, Inc.2023-07-05
Guardant360 CDx (P200010/S015)Guardant Health, Inc.2023-06-20
← Previous Next →

Track Pathology automatically

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