Atlas FDA

Pathology

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

Sort:Newest firstOldest first

◉ Watch Pathology

RecordFirmDate
Oncomine Dx Target Test (P160045/S023)Life Technologies Corporation2020-11-11
PD-L1 IHC 22C3 PharmDx (P150013/S019)Agilent Technologies, Inc.2020-11-06
cobas EGFR Mutation Test v2 (P120019/S031)Roche2020-10-27
FoundationOne Liquid CDx (F1 Liquid CDx) (P200006)Foundation Medicine, Inc.2020-10-26
FoundationOne CDx (F1CDx) (P170019/S017)Foundation Medicine, Inc.2020-10-23
Oncomine Dx Target Test (P160045/S021)Life Technologies Corporation2020-10-23
BOND Oracle HER2 IHC System (P090015/S012)Leica Biosystems2020-10-20
Cologuard (P130017/S044)Exact Sciences Corporation2020-10-20
FoundationOne CDx (P170019/S020)Foundation Medicine, Inc.2020-10-15
Oncomine Dx Target Test (P160045/S022)Life Technologies Corporation2020-10-08
Cologuard (P130017/S043)Exact Sciences Corporation2020-10-07
Oncomine Dx Target Test (P160045/S019)Life Technologies Corporation2020-09-04
Praxis Extended RAS Panel (P160038/S017)Illumina, Inc.2020-09-02
Cologuard (P130017/S042)Exact Sciences Corporation2020-08-26
cobas KRAS Mutation Test (P140023/S023)Roche Molecular Systems, Inc.2020-08-26
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S032)Roche2020-08-26
cobas® EZH2 Mutation Test (P200014/S001)Roche Molecular System, Inc.2020-08-26
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032)Foundation Medicine, Inc.2020-08-26
cobas BRAF V600 Mutation Test (P110020/S035)Roche Molecular Systems, Inc.2020-08-26
CINtec PLUS Cytology (P190024/S001)Ventana Medical Systems, Inc.2020-08-14
ThinPrep Processors and ThinPrep Imaging System (P950039/S039)Hologic, Inc.2020-08-12
Guardant360 CDx (P200010)Guardant Health, Inc.2020-08-07
HER2 Dual ISH DNA Probe Cocktail (P190031)Ventana Medical Systems, Inc.2020-07-28
FoundationOne CDx (F1CDx) (P170019/S019)Foundation Medicine, Inc.2020-07-24
Progensa PCA3 Assay (P100033/S012)Gen-Probe Incorporated2020-07-21
Cologuard (P130017/S037)Exact Sciences Corporation2020-07-14
HercepTest (P980018/S025)Agilent Technologies Singapore (International) Pte , Ltd.2020-06-30
cobas® EZH2 Mutation Test (P200014)Roche Molecular System, Inc.2020-06-18
FoundationOne CDx (F1CDx) (P170019/S016)Foundation Medicine, Inc.2020-06-16
Cologuard (P130017/S041)Exact Sciences Corporation2020-06-15
Progensa PCA3 Assay (P100033/S011)Gen-Probe Incorporated2020-06-08
Oncomine Dx Target Test (P160045/S020)Life Technologies Corporation2020-05-26
Vysis ALK Break Apart Fish Probe Kit (P110012/S020)Abbott Molecular, Inc.2020-05-22
FoundationOne CDx (P170019/S015)Foundation Medicine, Inc.2020-05-19
BRACAnalysis CDx (P140020/S020)Myriad Genetic Laboratories2020-05-19
cobas KRAS Mutation Test (P140023/S022)Roche Molecular Systems, Inc.2020-05-18
Ventana PD-L1 (SP142) Assay (P160002/S012)Ventana Medical Systems, Inc.2020-05-18
PD-L1 IHC 28-8 pharmDx (P150025/S013)Agilent Technologies, Inc.2020-05-15
LeukoStrat CDx FLT3 Mutation Assay (P160040/S006)Invivoscribe Technologies, Inc.2020-05-14
FoundationOne CDx (F1CDx) (P170019/S018)Foundation Medicine, Inc.2020-05-13
Cologuard (P130017/S040)Exact Sciences Corporation2020-05-12
myChoice CDx (P190014/S003)Myriad Genetic Laboratories, Inc.2020-05-08
FoundationOne CDx (F1CDx) (P170019/S011)Foundation Medicine, Inc.2020-05-06
myChoice CDx (P190014/S001)Myriad Genetic Laboratories, Inc.2020-04-29
Praxis Extended RAS Panel (P160038/S016)Illumina, Inc.2020-04-28
BOND Oracle HER2 IHC System (P090015/S011)Leica Biosystems2020-04-24
FoundationOne CDx (F1CDx) (P170019/S013)Foundation Medicine, Inc.2020-04-17
Cologuard (P130017/S039)Exact Sciences Corporation2020-04-13
therascreen EGFR RGQ PCR Kit (P120022/S021)QIAGEN GmbH2020-04-03
therascreen KRAS RGQ PCR Kit (P110027/S011)QIAGEN GmbH2020-04-03
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S042)Ventana Medical Systems, Inc.2020-03-31
VENTANA PD-L1(SP142) Assay (P160002/S011)Ventana Medical Systems, Inc.2020-03-31
VENTANA PD-L1 (SP263) Assay (P160046/S007)Ventana Medical Systems, Inc.2020-03-31
VENTANA ALK (D5F3) CDx Assay (P140025/S012)Ventana Medical Systems, Inc.2020-03-31
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S032)Ventana Medical Systems, Inc.2020-03-31
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S022)Ventana Medical Systems, Inc.2020-03-31
myChoice CDx (P190014/S002)Myriad Genetic Laboratories, Inc.2020-03-23
PD-L1 IHC 22C3 pharmDx (P150013/S017)Agilent Technologies, Inc.2020-03-19
Cologuard (P130017/S038)Exact Sciences Corporation2020-03-12
CINtec PLUS Cytology (P190024)Ventana Medical Systems, Inc.2020-03-10
PD-L1 IHC 22C3 PharmDx (P150013/S018)Agilent Technologies, Inc.2020-02-27
THxID-BRAF assay kit (P120014/S010)bioMerieux, Inc.2020-02-26
Praxis Extended RAS Panel (P160038/S015)Illumina, Inc.2020-01-24
BOND ORACLE HER2 IHC SYSTEM (P090015/S010)Leica Biosystems2020-01-02
BRACAnalysis CDx (P140020/S019)Myriad Genetic Laboratories2019-12-27
FoundationOne CDx (F1CDx) (P170019/S010)Foundation Medicine, Inc.2019-12-16
BD FocalPoint GS Imaging System (P950009/S023)Bd Diagnostics2019-12-06
FoundationOne CDx (P170019/S006)Foundation Medicine, Inc.2019-12-03
Ventana PD-Ll (SP263) Assay (P160046/S006)Ventana Medical Systems, Inc.2019-11-19
Inform HER2 Dual ISH DNA Probe Cocktail (P100027/S031)Ventana Medical Systems, Inc.2019-11-19
Ventana PD-Ll (SP142) Assay (P160002/S010)Ventana Medical Systems, Inc.2019-11-19
Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S041)Ventana Medical Systems, Inc.2019-11-19
Ventana ALK (D5F3) CDx Assay (P140025/S011)Ventana Medical Systems, Inc.2019-11-19
Oncomine Dx Target Test (P160045/S018)Life Technologies Corporation2019-11-13
FoundationOne CDx (P170019/S012)Foundation Medicine, Inc.2019-11-06
Praxis Extended RAS Panel (P160038/S014)Illumina, Inc.2019-11-04
Bond Oracle HER2 IHC System (P090015/S009)Leica Biosystems2019-10-25
COLOGUARD (P130017/S035)Exact Sciences Corporation2019-10-24
myChoice HRD CDx (P190014)Myriad Genetic Laboratories, Inc.2019-10-23
Cologuard (P130017/S036)Exact Sciences Corporation2019-10-22
Cologuard (P130017/S033)Exact Sciences Corporation2019-10-18
FoundationOne CDx (P170019/S007)Foundation Medicine, Inc.2019-10-11
cobas BRAF V600 Mutation Test (P110020/S034)Roche Molecular Systems, Inc.2019-10-10
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S030)Roche2019-10-10
cobas KRAS Mutation Test (P140023/S021)Roche Molecular Systems, Inc.2019-10-10
Cologaurd (P130017/S034)Exact Sciences Corporation2019-10-08
therascreen EGFR RGQ PCR Kit (P120022/S020)QIAGEN GmbH2019-09-26
cobas EGFR Mutation Test v2 (P120019/S029)Roche2019-09-25
cobas 4800 BRAF V600 Mutation Test (P110020/S033)Roche Molecular Systems, Inc.2019-09-25
Cologuard Stool DNA-Based Colorectal Cancer Screening Test (P130017/S029)Exact Sciences Corporation2019-09-20
BOND Oracel HER2 IHC System (P090015/S008)Leica Biosystems2019-09-12
Cologuard (P130017/S032)Exact Sciences Corporation2019-09-06
BD FocalPoint GS Imaging System (P950009/S022)Bd Diagnostics2019-09-05
ThinPrep 5000 Processor (P950039/S038)Hologic, Inc.2019-09-03
Epi proColon (P130001/S005)New Day Diagnostics, LLC2019-08-30
Vysis ALK Break Apart FISH Probe Kit (P110012/S019)Abbott Molecular, Inc.2019-08-26
UroVysion Bladder Cancer Kit (P030052/S026)Abbott Molecular2019-08-26
THxID BRAF assay kit (P120014/S009)bioMerieux, Inc.2019-08-26
FoundationOne CDx (F1CDx) (P170019/S009)Foundation Medicine, Inc.2019-08-21
Oncomine Dx Target Test (P160045/S016)Life Technologies Corporation2019-08-19
← Previous Next →

Track Pathology automatically

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