Atlas FDA

Pathology

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

Sort:Newest firstOldest first

◉ Watch Pathology

RecordFirmDate
cobas® EZH2 Mutation Test (P200014/S010)Roche Molecular System, Inc.2025-12-31
cobas® EGFR Mutation Test, v2.0 (P120019/S042)Roche2025-12-31
cobsa® BRAF V600 Mutation Test (P110020/S043)Roche Molecular Systems, Inc.2025-12-31
cobas® KRAS Mutation Test (P140023/S031)Roche Molecular Systems, Inc.2025-12-31
Guardant360 CDx (P200010/S028)Guardant Health, Inc.2025-12-29
PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059)Ventana Medical Systems, Inc.2025-12-15
HER2 Dual ISH DNA Probe Cocktail (P190031/S014)Ventana Medical Systems, Inc.2025-12-15
Cologuard® (P130017/S066)Exact Sciences Corporation2025-11-24
Oncomine™ Dx Target Test (P160045/S051)Life Technologies Corporation2025-11-21
Oncomine Dx Target Test (P160045/S050)Life Technologies Corporation2025-11-19
ColoSense® (P230001/S011)Geneoscopy, Inc.2025-10-24
Oncomine Dx Express Test (P240040/S003)Life Technologies Corporation2025-10-22
Oncomine Dx Express Test (P240040/S002)Life Technologies Corporation2025-10-15
Cologuard® (P130017/S065)Exact Sciences Corporation2025-10-07
Guardant360 CDx (P200010/S021)Guardant Health, Inc.2025-09-25
TruSight Oncology Comprehensive (P230011/S005)Illumina, Inc.2025-09-19
ColoSense® (P230001/S009)Geneoscopy, Inc.2025-09-15
TruSight Oncology Comprehensive (P230011/S004)Illumina, Inc.2025-09-05
CINtec PLUS Cytology (P190024/S015)Ventana Medical Systems, Inc.2025-09-04
ThinPrep Processor and ThinPrep Imaging System (P950039/S041)Hologic, Inc.2025-08-27
MMR IHC Panel pharmDx (Dako Omnis) (P250004)Agilent Technologies, Inc.2025-08-15
ColoSense® (P230001/S010)Geneoscopy, Inc.2025-08-14
Vysis CLL Fish Probe Kit (P150041/S007)Abbott Molecular, Inc.2025-08-08
Oncomine Dx Target Test (P160045/S049)Life Technologies Corporation2025-08-08
Oncomine™ Dx Express Test (P240040/S001)Life Technologies Corporation2025-08-07
Vysis ALK Break Apart FISH Probe Kit (P110012/S022)Abbott Molecular, Inc.2025-08-05
PD-L1 IHC 22C3 pharmDx (Dako Omnis) (P150013/S028)Agilent Technologies, Inc.2025-08-04
CINtec PLUS Cytology (P190024/S014)Ventana Medical Systems, Inc.2025-07-31
Cologuard Plus™ (P230043/S002)Exact Sciences Corporation2025-07-24
Cologuard® test (P130017/S064)Exact Sciences Corporation2025-07-24
Cologuard Plus™ (P230043/S001)Exact Sciences Corporation2025-07-18
Cologuard® (P130017/S063)Exact Sciences Corporation2025-07-18
VENTANA MET (SP44) RxDx Assay (P240037/S001)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2025-07-11
ColoSense® (P230001/S008)Geneoscopy, Inc.2025-07-03
Oncomine Dx Express Test (P240040)Life Technologies Corporation2025-07-02
xT CDx (P210011/S003)Tempus AI, Inc.2025-06-27
PD-L1 IHC 28-8 pharmDx (P150025/S017)Agilent Technologies, Inc.2025-06-27
MAGE-A4 IHC 1F9 pharmDx (P230016/S002)Agilent Technologies, Inc.2025-06-27
PD-L1 IHC 22C3 PHARMDX (P150013/S030)Agilent Technologies, Inc.2025-06-27
VENTANA MMR RxDx Panel (P200019/S012)Ventana Medical Systems2025-06-20
VENTANA MET (SP44) RxDx Assay (P240037/S002)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2025-06-20
VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001)Ventana Medical Systems, Inc.2025-06-20
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057)Ventana Medical Systems, Inc.2025-06-20
VENTANA ALK (D5F3) CDX ASSAY (P140025/S025)Ventana Medical Systems, Inc.2025-06-20
VENTANA PD-L1 (SP263) ASSAY (P160046/S020)Ventana Medical Systems, Inc.2025-06-20
PATHWAY® Anti-c-KIT (9.7) Primary Antibody (P020055/S032)Ventana Medical Systems, Inc.2025-06-20
VENTANA HER2 DualL ISH DNA Probe Cocktail (P190031/S013)Ventana Medical Systems, Inc.2025-06-16
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S056)Ventana Medical Systems, Inc.2025-06-11
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S012)Ventana Medical Systems, Inc.2025-05-16
VENTANA MET (SP44) RxDx Assay (P240037)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2025-05-14
ColoSense (P230001/S005)Geneoscopy, Inc.2025-05-14
CINtec PLUS Cytology (P190024/S013)Ventana Medical Systems, Inc.2025-04-25
TruSight Oncology Comprehensive (P230011/S003)Illumina, Inc.2025-04-18
VENTANA MMR RxDx Panel (P200019/S011)Ventana Medical Systems2025-04-17
VENTANA MMR RxDx Panel (P210001/S014)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2025-04-17
Cologuard® (P130017/S061)Exact Sciences Corporation2025-03-20
ColoHealth (P130001/S009)New Day Diagnostics, LLC2025-03-19
COLOGUARD (P130017/S062)Exact Sciences Corporation2025-03-14
VENTANA ALK (D5F3) CDx Assay (P140025/S024)Ventana Medical Systems, Inc.2025-03-12
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S002)Agilent Technologies, Inc.2025-02-28
PD-L1 IHC 22C3 pharmDx (P150013/S029)Agilent Technologies, Inc.2025-02-28
MAGE-A4 IHC 1F9 pharmDx (P230016/S001)Agilent Technologies, Inc.2025-02-28
PD-L1 IHC 28-8 pharmDx (P150025/S016)Agilent Technologies, Inc.2025-02-28
Guardant360 CDx (P200010/S022)Guardant Health, Inc.2025-02-07
UroVysion Bladder Cancer Kit (P030052/S029)Abbott Molecular2025-01-29
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S055)Ventana Medical Systems, Inc.2025-01-27
cobas EGFR Mutation Test v2 (P120019/S027)Roche2025-01-27
Guardant360 CDx (P200010/S023)Guardant Health, Inc.2025-01-22
FoundationOne CDx (P170019/S054)Foundation Medicine, Inc.2025-01-16
therascreen® KRAS RGQ PCR Kit (P110027/S018)QIAGEN GmbH2025-01-16
VENTANA MMR RxDx Panel (P200019/S010)Ventana Medical Systems2024-12-20
VENTANA MMR RxDx Panel (P210001/S012)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2024-12-20
FoundationOneCDx (F1CDx) (P170019/S056)Foundation Medicine, Inc.2024-12-19
ColoSense (P230001/S007)Geneoscopy, Inc.2024-12-19
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S028)Foundation Medicine, Inc.2024-12-18
VENTANA MMR RxDx Panel (P210001/S013)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2024-12-18
FoundationOne CDx (F1CDx) (P170019/S063)Foundation Medicine, Inc.2024-12-18
FoundationOne Liquid CDx (F1CDx) (P190032/S024)Foundation Medicine, Inc.2024-12-12
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S054)Ventana Medical Systems, Inc.2024-11-20
FoundationOne Liquid CDx (P190032/S015)Foundation Medicine, Inc.2024-11-14
COLOGUARD (P130017/S060)Exact Sciences Corporation2024-11-12
TruSight Oncology Comprehensive (P230011/S001)Illumina, Inc.2024-11-07
FoundationOne CDx (F1CDx) (P170019/S061)Foundation Medicine, Inc.2024-11-02
FoundationOne Liquid CDx (F1LCDx) (P190032/S026)Foundation Medicine, Inc.2024-11-02
FoundationOne CDx (P170019/S058)Foundation Medicine, Inc.2024-10-25
VENTANA PD-L1 (SP263) CDx Assay (P160046/S019)Ventana Medical Systems, Inc.2024-10-23
VENTANA CLDN18 (43-14A) RxDx Assay (P230018)Ventana Medical Systems, Inc.2024-10-18
Oncomine Dx Target Test (P160045/S046)Life Technologies Corporation2024-10-17
ColoSense (P230001/S006)Geneoscopy, Inc.2024-10-16
COBAS EGFR MUTATION TEST (P120019/S040)Roche2024-10-10
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S023)Foundation Medicine, Inc.2024-10-10
cobas® EZH2 Mutation Test (P200014/S009)Roche Molecular System, Inc.2024-10-10
MyChoice® CDx (P190014/S010)Myriad Genetic Laboratories, Inc.2024-10-04
BRACAnalysis CDx® (P140020/S029)Myriad Genetic Laboratories2024-10-04
Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™ (P230043)Exact Sciences Corporation2024-10-03
LeukoStrat CDx FLT3 Mutation Assay (P160040/S013)Invivoscribe Technologies, Inc.2024-09-27
ColoSense® (P230001/S004)Geneoscopy, Inc.2024-09-06
BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test (P970018/S041)Bd Diagnostic Systems2024-09-06
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) (P210026/S001)Agilent Technologies, Inc.2024-09-04
FoundationOne®Liquid CDx (F1LCDx) (P190032/S016)Foundation Medicine, Inc.2024-08-30
Next →

Track Pathology automatically

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