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Pathology

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

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RecordFirmDate
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S045)Ventana Medical Systems, Inc.2022-06-10
VENTANA PD-L1(SP142) Assay (P160002/S016)Ventana Medical Systems, Inc.2022-06-10
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S035)Ventana Medical Systems, Inc.2022-06-10
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S025)Ventana Medical Systems, Inc.2022-06-10
FoundationOne CDx (P170019/S014)Foundation Medicine, Inc.2022-06-07
FoundationOne Liquid CDx (P190032/S003)Foundation Medicine, Inc.2022-05-25
VENTANA MMR RxDx Panel (P210001/S005)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2022-05-20
Guardant360 CDx (P200010/S004)Guardant Health, Inc.2022-05-18
FoundationOne CDx (P170019/S032)Foundation Medicine, Inc.2022-05-06
FoundationOne CDx (FICDx) (P170019/S034)Foundation Medicine, Inc.2022-04-13
Cologuard (P130017/S051)Exact Sciences Corporation2022-04-13
LeukoStrat CDx FLT3 Mutation Assay (P160040/S010)Invivoscribe Technologies, Inc.2022-04-11
Praxis Extended RAS Panel (P160038/S021)Illumina, Inc.2022-03-28
VENTANA MMR RxDx Panel (P210001/S001)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2022-03-21
UroVysion Bladder Cancer Kit (P030052/S028)Abbott Molecular2022-03-18
PathVysion HER-2 DNA Probe Kit (P980024/S022)Abbott Molecular, Inc.2022-03-18
FoundationOne CDx (FICDx) (P170019/S033)Foundation Medicine, Inc.2022-03-16
Guardant360 CDx (P200010/S005)Guardant Health, Inc.2022-03-16
BRACAnalysis CDx® (P140020/S022)Myriad Genetic Laboratories2022-03-11
Guardant360® CDx (P200010/S007)Guardant Health, Inc.2022-02-28
FoundationOne CDx (F1CDx) (P170019/S029)Foundation Medicine, Inc.2022-02-18
myChoice CDx (P190014/S006)Myriad Genetic Laboratories, Inc.2022-02-10
PD-L1 IHC 22C3 pharmDx (P150013/S024)Agilent Technologies, Inc.2022-02-08
FoundationOne Liquid CDx (P200006/S001)Foundation Medicine, Inc.2022-02-03
PD-L1 IHC 22C3 pharmDx (P150013/S022)Agilent Technologies, Inc.2022-01-31
Oncomine Dx Target Test (P160045/S034)Life Technologies Corporation2022-01-21
FoundationOne CDx (F1CDx) (P170019/S030)Foundation Medicine, Inc.2022-01-19
BD Totalys MultiProcessor (P970018/S039)Bd Diagnostic Systems2021-12-21
THXID™-BRAF (P120014/S012)bioMerieux, Inc.2021-12-20
Cologuard® (P130017/S050)Exact Sciences Corporation2021-12-13
Oncomine™ Dx Target Test (P160045/S027)Life Technologies Corporation2021-12-01
BD FocalPoint GS Imaging System (P950009/S025)Bd Diagnostics2021-11-23
PD-L1 IHC 22C3 pharmDx (P150013/S023)Agilent Technologies, Inc.2021-11-23
FoundationOne CDx (F1CDx) (P170019/S028)Foundation Medicine, Inc.2021-11-18
FoundationOne CDx (P170019/S025)Foundation Medicine, Inc.2021-11-10
PD-L1 IHC 28-8 pharmDx (P150025/S014)Agilent Technologies, Inc.2021-10-18
VENTANA PD-L1 (SP263) Assay (P160046/S010)Ventana Medical Systems, Inc.2021-10-15
Ki-67 IHC pharmDx (P210026)Agilent Technologies, Inc.2021-10-12
Cologuard (P130017/S049)Exact Sciences Corporation2021-10-06
VENTANA PD-L1 (SP142) Assay (P160002/S015)Ventana Medical Systems, Inc.2021-09-28
Epi proColon (P130001/S007)New Day Diagnostics, LLC2021-09-20
Oncomine Dx Target Test (ODxT Test) (P160045/S029)Life Technologies Corporation2021-09-15
LeukoStrat CDx FLT3 Mutation Assay (P160040/S007)Invivoscribe Technologies, Inc.2021-08-26
Oncomine™ Dx Target Test (P160045/S028)Life Technologies Corporation2021-08-25
VENTANA MMR RxDx Panel (P210001)Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)2021-08-17
LeukoStrat CDx FLT3 Mutation Assay (P160040/S009)Invivoscribe Technologies, Inc.2021-08-11
cobas® EZH2 Mutation Test (P200014/S003)Roche Molecular System, Inc.2021-08-10
LeukoStrat CDx FLT3 Mutation Assay (P160040/S008)Invivoscribe Technologies, Inc.2021-08-05
FoundationOne CDx (F1CDx) (P170019/S026)Foundation Medicine, Inc.2021-07-30
Praxis Extended RAS Panel (P160038/S019)Illumina, Inc.2021-07-29
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S013)Foundation Medicine, Inc.2021-07-21
FoundationOne CDx, FoundationOne Liquid CDx (P170019/S022)Foundation Medicine, Inc.2021-07-21
FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S001)Foundation Medicine, Inc.2021-07-15
therascreen EGFR RGQ PCR Kit (P120022/S022)QIAGEN GmbH2021-07-07
BRACAnalysis CDx (P140020/S021)Myriad Genetic Laboratories2021-07-02
FoundationOne CDx (F1CDx) (P170019/S023)Foundation Medicine, Inc.2021-06-30
myChoice HRD CDx (P190014/S005)Myriad Genetic Laboratories, Inc.2021-06-24
Oncomine Dx Target Test (P160045/S030)Life Technologies Corporation2021-06-11
therascreen KRAS RGQ PCR KIT (P110027/S012)QIAGEN GmbH2021-05-28
Guardant360 CDx (P200010/S002)Guardant Health, Inc.2021-05-28
FoundationOne CDx (F1CDx) (P170019/S021)Foundation Medicine, Inc.2021-05-28
Guardant360 CDx (P200010/S001)Guardant Health, Inc.2021-05-21
Praxis Extended RAS Panel (P160038/S020)Illumina, Inc.2021-05-21
BD PrepStain System (P970018/S038)Bd Diagnostic Systems2021-05-20
VENTANA HER2 Dual ISI-I DNA Probe Cocktail (P190031/S002)Ventana Medical Systems, Inc.2021-05-20
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S044)Ventana Medical Systems, Inc.2021-05-20
VENTANA PD-LI (SP142) Assay (P160002/S014)Ventana Medical Systems, Inc.2021-05-20
PATI-IWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S024)Ventana Medical Systems, Inc.2021-05-20
VENTANA PD-LI (SP263) Assay (P160046/S009)Ventana Medical Systems, Inc.2021-05-20
VENTANA ALK (D5F3) CDx Assay (P140025/S015)Ventana Medical Systems, Inc.2021-05-20
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S034)Ventana Medical Systems, Inc.2021-05-20
CINtec PLUS Cytology (P190024/S003)Ventana Medical Systems, Inc.2021-05-20
ThinPrep Genesis Processor (P950039/S040)Hologic, Inc.2021-05-14
VENTANA MMR RxDx Panel (P200019)Ventana Medical Systems2021-04-22
Cologuard (P130017/S046)Exact Sciences Corporation2021-04-12
BD FocalPoint GS Imaging System (P950009/S024)Bd Diagnostics2021-03-29
CINtec PLUS Cytology (P190024/S004)Ventana Medical Systems, Inc.2021-03-29
Cologuard (P130017/S048)Exact Sciences Corporation2021-03-25
Cologuard (P130017/S047)Exact Sciences Corporation2021-03-17
THxID-BRAF kit (P120014/S011)bioMerieux, Inc.2021-03-10
VENTANA ALK (D5F3) CDx Assay (P140025/S014)Ventana Medical Systems, Inc.2021-03-03
PD-L1 IHC 22C3 pharmDx (P150013/S021)Agilent Technologies, Inc.2021-02-22
BD PrepStain System (P970018/S037)Bd Diagnostic Systems2021-02-16
myChoice CDx (P190014/S004)Myriad Genetic Laboratories, Inc.2021-01-27
UroVysion Bladder Cancer Kit (P030052/S027)Abbott Molecular2020-12-11
PathVysion HER-2 DNA Probe Kit (P980024/S021)Abbott Molecular, Inc.2020-12-11
Vysis CLL FISH Probe Kit (P150041/S006)Abbott Molecular, Inc.2020-12-11
Vysis ALK Break Apart FISH Probe Kit (P110012/S021)Abbott Molecular, Inc.2020-12-11
Praxis Extended RAS Panel (P160038/S018)Illumina, Inc.2020-12-04
Oncomine Dx Target Test (P160045/S024)Life Technologies Corporation2020-12-01
Cologuard (P130017/S045)Exact Sciences Corporation2020-11-25
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S023)Ventana Medical Systems, Inc.2020-11-13
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S033)Ventana Medical Systems, Inc.2020-11-13
PD-L1 IHC 22C3 pharmDX (P150013/S020)Agilent Technologies, Inc.2020-11-13
VENTANA PD-L1 (SP142) Assay (P160002/S013)Ventana Medical Systems, Inc.2020-11-13
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S001)Ventana Medical Systems, Inc.2020-11-13
VENTANA ALK (D5F3) CDx Assay (P140025/S013)Ventana Medical Systems, Inc.2020-11-13
VENTANA PD-L1 (SP263) Assay (P160046/S008)Ventana Medical Systems, Inc.2020-11-13
CINtec PLUS Cytology (P190024/S002)Ventana Medical Systems, Inc.2020-11-13
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S043)Ventana Medical Systems, Inc.2020-11-13
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Every clearance here is in the API, with alerts when new ones post.