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Pathology

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

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RecordFirmDate
PD-L1 IHC NIVOLUMAB PHARMDX (P150027/S004)Dako North America, Inc.2017-03-24
DAKO HERCEPTEST (P980018/S023)Agilent Technologies Singapore (International) Pte , Ltd.2017-03-24
VENTANA ALK (D5F3) (P140025/S004)Ventana Medical Systems, Inc.2017-03-13
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S026)Ventana Medical Systems, Inc.2017-03-13
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S035)Ventana Medical Systems, Inc.2017-03-13
PATHWAY ANTI-C-KIT (P020055/S019)Ventana Medical Systems, Inc.2017-03-13
PD-L1 IHC 28-8 PHARMDX (P150027/S003)Dako North America, Inc.2017-02-24
BOND ORACLE HER2 IHC SYSTEM (P090015/S004)Leica Biosystems2017-02-15
BRACANALYSIS CDX (P140020/S008)Myriad Genetic Laboratories2017-01-30
VENTANA PD-L1(SP142) CDX ASSAY (P160002/S001)Ventana Medical Systems, Inc.2016-12-21
FoundationFocus CDxBRCA (P160018)Foundation Medicine, Inc.2016-12-19
COLOGUARD (P130017/S014)Exact Sciences Corporation2016-12-13
BD SUREPATH COLLECTION VIAL (P970018/S033)Bd Diagnostic Systems2016-12-02
PD-L1 IHC 28-8 PHARMDX (Non-Squamous Indication) (P150025/S002)Agilent Technologies, Inc.2016-12-01
COLOGUARD (P130017/S013)Exact Sciences Corporation2016-12-01
PD-L1 IHC 22C3 PHARMDX (P150013/S003)Agilent Technologies, Inc.2016-12-01
PD-L1 IHC 28-8 PHARMDX (Melanoma Indication) (P150027/S002)Dako North America, Inc.2016-12-01
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S025)Ventana Medical Systems, Inc.2016-11-30
THxID-BRAF kit (P120014/S007)bioMerieux, Inc.2016-11-22
Epi proColon (P130001/S001)New Day Diagnostics, LLC2016-11-18
COLOGUARD (P130017/S012)Exact Sciences Corporation2016-11-17
Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST (P110020/S016)Roche Molecular Systems, Inc.2016-11-07
THINPREP PROCESSOR, (P950039/S035)Hologic, Inc.2016-10-26
PD-L1 IHC 22C3 PHARMDX (P150013/S001)Agilent Technologies, Inc.2016-10-24
VENTANA ALK (D5F3) CDX ASSAY (P140025/S003)Ventana Medical Systems, Inc.2016-10-21
cobas EGFR Mutation Test and cobas® EGFR Mutation Test, v2 (P120019/S012)Roche2016-10-19
COBAS KRAS MUTATION TEST (P140023/S008)Roche Molecular Systems, Inc.2016-10-19
Cobas EGFR MUTATION TEST v2 (P150047/S002)Roche Molecular Systems, Inc.2016-10-19
VENTANA PD-L1 (SP142) Assay (P160006)Ventana Medical Systems, Inc.2016-10-18
Epi proColon (P130001/S002)New Day Diagnostics, LLC2016-10-18
URO VYSION BLADDER CANCER KIT (P030052/S019)Abbott Molecular2016-10-11
VYSIS ALK BREAK APART FISH PROBE KIT. (P110012/S012)Abbott Molecular, Inc.2016-10-11
PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION) (P150025/S001)Agilent Technologies, Inc.2016-10-05
PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION) (P150027/S001)Dako North America, Inc.2016-10-05
UROVYSION BLADDER CANCER KIT (P030052/S018)Abbott Molecular2016-09-29
PATHVYSION HER-2 DNA PROBE KIT (P980024/S015)Abbott Molecular, Inc.2016-09-29
Vysis ALK Break Apart FISH Probe Kit (P110012/S011)Abbott Molecular, Inc.2016-09-29
cobas EGFR MUTATION TEST v2 (P150044)Roche Molecular Systems, Inc.2016-09-28
HER2 CISH PHARMDX KIT (P100024/S010)Dako Denmark A/S2016-09-27
COBAS KRAS MUTATION TEST (P140023/S004)Roche Molecular Systems, Inc.2016-09-24
PD-L1 IHC 22C3 PHARMDX (P150013/S002)Agilent Technologies, Inc.2016-09-23
COBAS KRAS MUTATION TEST (P140023/S007)Roche Molecular Systems, Inc.2016-09-20
COBAS EGFR MUTATION TEST (P150047/S001)Roche Molecular Systems, Inc.2016-09-20
COBAS EGFR MUTATION TEST (P120019/S011)Roche2016-09-20
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S018)Roche Molecular Systems, Inc.2016-09-20
THERASCREEN EGFR RGQ PCR KIT (P120022/S013)QIAGEN GmbH2016-09-07
COLOGUARD (P130017/S010)Exact Sciences Corporation2016-08-19
COBAS EGFR MUTATION TEST (P120019/S010)Roche2016-08-04
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S017)Roche Molecular Systems, Inc.2016-08-04
COBAS KRAS MUTATION TEST (P140023/S006)Roche Molecular Systems, Inc.2016-08-04
COLOGUARD (P130017/S011)Exact Sciences Corporation2016-07-26
BRACANALYSIS CDX (P140020/S002)Myriad Genetic Laboratories2016-07-26
HERCEPTEST (P980018/S022)Agilent Technologies Singapore (International) Pte , Ltd.2016-07-22
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S010)Abbott Molecular, Inc.2016-07-13
PATH VYSION HER-2 DNA PROBE KIT (P980024/S014)Abbott Molecular, Inc.2016-07-13
BD TOTALYS SLIDEPREP (P970018/S034)Bd Diagnostic Systems2016-06-17
BD FOCALPOINT GS IMAGING SYSTEM (P950009/S021)Bd Diagnostics2016-06-17
BRACANALYSIS CDx (P140020/S007)Myriad Genetic Laboratories2016-06-17
BRACANALYSIS CDX (P140020/S006)Myriad Genetic Laboratories2016-06-17
cobas EGFR MUTATION TEST v2 (P150047)Roche Molecular Systems, Inc.2016-06-01
DAKO HERCEPTEST (P980018/S021)Agilent Technologies Singapore (International) Pte , Ltd.2016-05-27
VENTANA PD-L1(SP142) CDX ASSAY (P160002)Ventana Medical Systems, Inc.2016-05-18
COBAS KRAS MUTATION TEST (P140023/S005)Roche Molecular Systems, Inc.2016-05-13
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S015)Roche Molecular Systems, Inc.2016-05-13
COBAS EGFR MUTATION TEST (P120019/S009)Roche2016-05-13
COLOGUARD (P130017/S009)Exact Sciences Corporation2016-05-05
COLOGUARD (P130017/S008)Exact Sciences Corporation2016-05-03
BRACANALYSIS CDX (P140020/S001)Myriad Genetic Laboratories2016-04-29
COBAS KRAS MUTATION TEST (P140023/S003)Roche Molecular Systems, Inc.2016-04-25
COLOGUARD (P130017/S007)Exact Sciences Corporation2016-04-20
AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009/S020)Bd Diagnostics2016-04-19
VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL) (P020055/S018)Ventana Medical Systems, Inc.2016-04-13
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S024)Ventana Medical Systems, Inc.2016-04-13
VENTANA ALK (D5F3) CDX ASSAY (P140025/S002)Ventana Medical Systems, Inc.2016-04-13
PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S034)Ventana Medical Systems, Inc.2016-04-13
Epi proColon (P130001)New Day Diagnostics, LLC2016-04-12
DAKOCYTOMATION HER2 FISH PHARMDX KIT (P040005/S013)Agilent Technologies Singapore (International) Pte , Ltd.2016-04-12
HER2 CISH PHARMDX KIT (P100024/S009)Dako Denmark A/S2016-04-12
VYSIS CLL FISH PROBE KIT (P150041)Abbott Molecular, Inc.2016-04-11
THXID-BRAF KIT (P120014/S006)bioMerieux, Inc.2016-04-05
BRACANALYSIS CDX DEVICE (P140020/S005)Myriad Genetic Laboratories2016-02-18
BD PREPSTAIN SYSTEM (P970018/S032)Bd Diagnostic Systems2016-02-12
BD FOCALPOINT SLIDE PROFILER (P950009/S018)Bd Diagnostics2016-02-12
BD TOTALYS SLIDEPREP (P970018/S030)Bd Diagnostic Systems2016-02-12
COLOGUARD (P130017/S006)Exact Sciences Corporation2016-02-04
HER2 CISH PHARMDX KIT (P100024/S008)Dako Denmark A/S2016-01-29
HER2 IQFISH PHARMDX (P040005/S012)Agilent Technologies Singapore (International) Pte , Ltd.2016-01-29
PD-L1 IHC 28-8 pharmDx (P150027)Dako North America, Inc.2016-01-23
THINPREP PROCESSORS (P950039/S034)Hologic, Inc.2016-01-11
UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT (P030052/S017)Abbott Molecular2015-12-29
COLOGUARD (P130017/S005)Exact Sciences Corporation2015-12-23
BRACANALYSIS CDX (P140020/S004)Myriad Genetic Laboratories2015-12-22
BRACANALYSIS CDX (P140020/S003)Myriad Genetic Laboratories2015-11-18
COBAS EGFR MUTATION TEST V2 (P120019/S007)Roche2015-11-13
PROGENSA PCA3 ASSAY (P100033/S004)Gen-Probe Incorporated2015-11-12
THERASCREEN KRAS RGQ PCR KIT (P110027/S009)QIAGEN GmbH2015-11-09
THERASCREEN EGFR RGQ PCR KIT (P120022/S012)QIAGEN GmbH2015-11-09
PD-L1 IHC 28-8 pharmDx (P150025)Agilent Technologies, Inc.2015-10-09
PD-L1 IHC 22C3 PHARMDX (P150013)Agilent Technologies, Inc.2015-10-02
COLOGUARD (P130017/S004)Exact Sciences Corporation2015-09-25
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