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Pathology

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

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RecordFirmDate
THxID BRAF assay kit (P120014/S008)bioMerieux, Inc.2018-06-27
Praxis Extended RAS Panel (P160038/S004)Illumina, Inc.2018-06-25
BD PrepStain System (P970018/S036)Bd Diagnostic Systems2018-06-21
PD-L1 IHC 22C3 pharmDx (P150013/S009)Agilent Technologies, Inc.2018-06-12
Ventana PD-L1 (SP263) (P160046/S004)Ventana Medical Systems, Inc.2018-06-01
Oncomine Dx Target Test (P160045/S006)Life Technologies Corporation2018-05-25
MiSeqDx Praxis Extended RAS Panel (P160038/S003)Illumina, Inc.2018-05-01
cobas EGFR Mutation Test v2 (P120019/S018)Roche2018-04-18
ThinPrep Integrated Imager (P950039/S036)Hologic, Inc.2018-04-18
cobas EGFR Mutation Test v2 (P120019/S016)Roche2018-04-18
Praxis Extended RAS Panel (P160038/S001)Illumina, Inc.2018-04-11
EGFR pharmDx (P030044/S005)Agilent Technologies, Inc.2018-04-10
PD-L1 IHC 22C3 PharmDx (P150013/S010)Agilent Technologies, Inc.2018-04-10
PD-L1 IHC 28-8 pharmDx (P150025/S009)Agilent Technologies, Inc.2018-04-10
FoundationFocus CDx BRCA HRD (P160018/S001)Foundation Medicine, Inc.2018-04-06
therascreen KRAS RGQ PCR Kit (P110027/S010)QIAGEN GmbH2018-04-06
therascreen EGFR RGQ PCR Kit (P120022/S019)QIAGEN GmbH2018-04-06
Cobas 4800 BRAF V600 Mutation Test (P110020/S024)Roche Molecular Systems, Inc.2018-03-27
Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2 (P120019/S020)Roche2018-03-27
Cobas KRAS Mutation Test (P140023/S013)Roche Molecular Systems, Inc.2018-03-27
Praxis Extended RAS Panel (P160038/S002)Illumina, Inc.2018-03-26
Epi proColon (P130001/S004)New Day Diagnostics, LLC2018-03-20
UroVysion Bladder Cancer Kit (P030052/S022)Abbott Molecular2018-03-12
Vysis ALK Break Apart Fish Probe Kit (P110012/S015)Abbott Molecular, Inc.2018-03-12
Path Vysion HER-2 DNA Probe Kit (P980024/S017)Abbott Molecular, Inc.2018-03-12
Vysis CLL FISH Probe Kit (P150041/S002)Abbott Molecular, Inc.2018-03-12
Progensa PCA3 Assay (P100033/S008)Gen-Probe Incorporated2018-03-07
Cologuard (P130017/S022)Exact Sciences Corporation2018-03-07
therascreen EGFR RGQ PCR kit (P120022/S017)QIAGEN GmbH2018-02-22
Hercep Test (P980018/S024)Agilent Technologies Singapore (International) Pte , Ltd.2018-02-08
EGFR pharmDx (P030044/S004)Agilent Technologies, Inc.2018-01-22
PD L1 IHC 22C3 pharmDx (P150013/S008)Agilent Technologies, Inc.2018-01-22
PD-L1 IHC 28-8 pharmDx (P150025/S008)Agilent Technologies, Inc.2018-01-22
LeukoStrat CDx FLT3 Mutation Assay (P160040/S001)Invivoscribe Technologies, Inc.2018-01-19
BD Totalys SlidePrep (P970018/S035)Bd Diagnostic Systems2018-01-12
Therascreen EGFR RGQ PCR Kit (P120022/S016)QIAGEN GmbH2018-01-12
BRACAnalysis CDx (P140020/S012)Myriad Genetic Laboratories2018-01-12
Oncomine Dx Target Test (P160045/S003)Life Technologies Corporation2017-12-18
Cologuard (P130017/S021)Exact Sciences Corporation2017-12-18
Oncomine Dx Target Test (P160045/S002)Life Technologies Corporation2017-12-06
Vysis CLL Fish Probe Kit (P150041/S001)Abbott Molecular, Inc.2017-12-06
Path Vysion HER-2 DNA Probe Kit (P980024/S016)Abbott Molecular, Inc.2017-12-06
Vysis ALK Break Apart Fish Probe Kit (P110012/S014)Abbott Molecular, Inc.2017-12-06
UroVysion Bladder Cancer Kit (P030052/S021)Abbott Molecular2017-12-06
FoundationOne CDx (P170019)Foundation Medicine, Inc.2017-11-30
PD-L1 IHC 22C3 pharmDx (P150013/S007)Agilent Technologies, Inc.2017-11-20
Cobas 4800 BRAF V600 Mutation Test (P110020/S023)Roche Molecular Systems, Inc.2017-11-13
Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test (P120019/S017)Roche2017-11-13
Cobas KRAS Mutation Test (P140023/S012)Roche Molecular Systems, Inc.2017-11-13
Cologuard (P130017/S017)Exact Sciences Corporation2017-11-06
VENTANA ALK (D5F3) CDx Assay (P140025/S006)Ventana Medical Systems, Inc.2017-11-06
Progensa PCA3 Assay (P100033/S007)Gen-Probe Incorporated2017-11-03
BRACAnalysis CDx Device (P140020/S013)Myriad Genetic Laboratories2017-10-26
Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit (P140023/S011)Roche Molecular Systems, Inc.2017-10-16
Roche cobas DNA Sample Preparation Kit / Roche cobas 4800 BRAF V600 Mutation Test (P110020/S022)Roche Molecular Systems, Inc.2017-10-13
Roche cobas EGFR Mutation Test / Roche cobas DNA Sample Preparation Kit (P120019/S015)Roche2017-10-13
PD-L1 IHC 22C3 pharmDx (P150013/S006)Agilent Technologies, Inc.2017-09-22
PD-L1 IHC 28-8 PHARMDX (P150025/S003)Agilent Technologies, Inc.2017-09-15
cobas KRAS Mutation Test (P140023/S010)Roche Molecular Systems, Inc.2017-08-15
cobas 4800 BRAF V600 Mutation Test (P110020/S021)Roche Molecular Systems, Inc.2017-08-15
cobas EGFR Mutation Test v2 (P120019/S014)Roche2017-08-15
Oncomine Dx Target Test (P160045/S001)Life Technologies Corporation2017-08-14
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S020)Roche Molecular Systems, Inc.2017-08-11
cobas KRAS Mutation Test (P140023/S009)Roche Molecular Systems, Inc.2017-08-09
cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S013)Roche2017-08-09
cobas BRAF V600 Mutation Test (P110020/S019)Roche Molecular Systems, Inc.2017-08-09
Cologuard (P130017/S020)Exact Sciences Corporation2017-08-08
Pathway Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody (P020055/S020)Ventana Medical Systems, Inc.2017-08-04
Ventana PD-L1 (SP142) Assay (P160002/S003)Ventana Medical Systems, Inc.2017-08-04
Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S036)Ventana Medical Systems, Inc.2017-08-04
Inform HER2 Dual ISH DNA Probe Cocktail (P100027/S027)Ventana Medical Systems, Inc.2017-08-04
Ventana PD-L1 (SP263) Assay (P160046/S001)Ventana Medical Systems, Inc.2017-08-04
Ventana ALK (D5F3) CDx Assay (P140025/S007)Ventana Medical Systems, Inc.2017-08-04
BOND Oracle HER2 IHC System (P090015/S005)Leica Biosystems2017-07-25
Therascreen EGFR, RGQ, PCR Kit (P120022/S015)QIAGEN GmbH2017-07-24
Cologuard (P130017/S018)Exact Sciences Corporation2017-06-30
Praxis Extended RAS Panel (P160038)Illumina, Inc.2017-06-29
Cologuard (P130017/S019)Exact Sciences Corporation2017-06-23
Oncomine Dx Target Test (P160045)Life Technologies Corporation2017-06-22
Ventana PD-L1 (SP142) Assay (P160002/S002)Ventana Medical Systems, Inc.2017-06-06
VENTANA ALK (D5F3) CDX ASSAY (P140025/S005)Ventana Medical Systems, Inc.2017-05-26
Cologuard (P130017/S015)Exact Sciences Corporation2017-05-24
THERASCREEN EGFR RGQ PCR KIT (P120022/S014)QIAGEN GmbH2017-05-19
COLOGUARD (P130017/S016)Exact Sciences Corporation2017-05-17
PD-L1 IHC 28-8 pharmDx (P150025/S006)Agilent Technologies, Inc.2017-05-16
EGFR pharmDx (P030044/S003)Agilent Technologies, Inc.2017-05-16
C-Kit pharmDx (P040011/S003)Dako North America, Inc.2017-05-16
PD-L1 IHC 22C3 pharmDx (P150013/S005)Agilent Technologies, Inc.2017-05-16
PD-L1 IHC 28-8 pharmDx (P150025/S005)Agilent Technologies, Inc.2017-05-03
VENTANA PD-L1 (SP263) ASSAY (P160046)Ventana Medical Systems, Inc.2017-05-01
LeukoStrat CDx FLT3 Mutation Assay (P160040)Invivoscribe Technologies, Inc.2017-04-28
HER2 CISH pharmDX Kit (P100024/S012)Dako Denmark A/S2017-04-12
Urovysion Bladder Cancer Kit (P030052/S020)Abbott Molecular2017-04-12
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S013)Abbott Molecular, Inc.2017-04-12
HER2 IQFISH pharmDx (P040005/S014)Agilent Technologies Singapore (International) Pte , Ltd.2017-04-12
HER2 CISH pharmDx Kit (P100024/S013)Dako Denmark A/S2017-04-03
BRACAnalysis CDx (P140020/S009)Myriad Genetic Laboratories2017-03-27
HER2 CISH PHARMDX KIT (P100024/S011)Dako Denmark A/S2017-03-24
PD-L1 IHC NIVOLUMAB PHARMDX (P150025/S004)Agilent Technologies, Inc.2017-03-24
PD-L1 IHC 22C3 PHARMDX (P150013/S004)Agilent Technologies, Inc.2017-03-24
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