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Pathology

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

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RecordFirmDate
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S033)Ventana Medical Systems, Inc.2015-09-24
VENTANA ALK (D5F3) CDX ASSAY (P140025/S001)Ventana Medical Systems, Inc.2015-09-24
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S023)Ventana Medical Systems, Inc.2015-09-24
VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL) (P020055/S017)Ventana Medical Systems, Inc.2015-09-24
PROGENSA PCA3 ASSAY (P100033/S006)Gen-Probe Incorporated2015-09-24
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P140023/S002)Roche Molecular Systems, Inc.2015-09-24
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S022)Ventana Medical Systems, Inc.2015-09-11
PATHWAYANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S032)Ventana Medical Systems, Inc.2015-09-11
HER2 IQFISH PHARMDX (P040005/S011)Agilent Technologies Singapore (International) Pte , Ltd.2015-09-10
HERCEP TEST (P980018/S020)Agilent Technologies Singapore (International) Pte , Ltd.2015-09-10
HER2 CISH PHARMDX KIT (P100024/S007)Dako Denmark A/S2015-09-10
COLOGUARD (P130017/S003)Exact Sciences Corporation2015-08-19
COLOGUARD (P130017/S002)Exact Sciences Corporation2015-08-18
THERASCREEN KRAS RGQ PCR KIT (P110027/S008)QIAGEN GmbH2015-08-06
THERASCREEN EGFR RGQ PCR KIT (P120022/S010)QIAGEN GmbH2015-08-06
ROCHE COBAS DNA SAMPLE PREPARATION KIT, ROCHE COBAS 4800 BRAF V600 MUTATION TEST (P110020/S014)Roche Molecular Systems, Inc.2015-07-23
ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P120019/S008)Roche2015-07-23
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P140023/S001)Roche Molecular Systems, Inc.2015-07-23
BD FOCALPOINT SLIDE PROFILER (P950009/S019)Bd Diagnostics2015-07-23
THERASCEEN EGFR RGQ PCR KIT (P120022/S001)QIAGEN GmbH2015-07-10
PROGENSA PCA3 ASSAY (P100033/S005)Gen-Probe Incorporated2015-07-09
VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT (P110012/S009)Abbott Molecular, Inc.2015-07-02
BD PREPMATE SLIDE PROCESSOR, BD PREPMATE AUTOMATED ACCESSORY (P970018/S031)Bd Diagnostic Systems2015-06-14
VENTANA ALK (D5F3) CDX ASSAY (P140025)Ventana Medical Systems, Inc.2015-06-12
THXID BRAF KIT (P120014/S005)bioMerieux, Inc.2015-06-05
THINPREP IMAGING SYSTEM (P020002/S010)Hologic, Inc.2015-06-02
THXID BRAF KIT (P120014/S003)bioMerieux, Inc.2015-05-27
HERCEP TEST (P980018/S019)Agilent Technologies Singapore (International) Pte , Ltd.2015-05-21
LEICA BOND ORACLE HER2 IHC SYSTEM (P090015/S003)Leica Biosystems2015-05-20
COBAS KRAS MUTATION TEST (P140023)Roche Molecular Systems, Inc.2015-05-07
QIAGEN THERASCREEN KRAS RGQ PCR KIT (P110027/S007)QIAGEN GmbH2015-04-24
QIAGEN THERASCREEN EGFR RGQ PCR KIT (P120022/S009)QIAGEN GmbH2015-04-24
QIAGEN THERASCREEN KRAS RGQ PCR KIT (P110027/S006)QIAGEN GmbH2015-04-23
QIAGEN THERASCREEN EGFR RGQ PCR KIT (P120022/S008)QIAGEN GmbH2015-04-23
PROGENSA PCA3 ASSAY (P100033/S003)Gen-Probe Incorporated2015-04-16
COBAS EGFR MUTATION TEST (P120019/S006)Roche2015-04-09
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S013)Roche Molecular Systems, Inc.2015-04-09
THXID BRAF KIT (P120014/S004)bioMerieux, Inc.2015-04-01
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S021)Ventana Medical Systems, Inc.2015-03-19
THINPREP-5000 (P950039/S026)Hologic, Inc.2015-03-02
PATHWAY ANTI-HER/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S030)Ventana Medical Systems, Inc.2015-02-19
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S019)Ventana Medical Systems, Inc.2015-02-19
THERASCREEN EGFR RGQ PCR KIT (P120022/S007)QIAGEN GmbH2015-02-19
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S015)Ventana Medical Systems, Inc.2015-02-19
THERASCREEN KRAS RGQ PCR KIT (P110027/S005)QIAGEN GmbH2015-02-19
BOND ORACLE HER2 IHC SYSTEM (P090015/S002)Leica Biosystems2015-02-13
QIAGEN THERASCREEN KRAS RGQ PCR KIT (P110027/S004)QIAGEN GmbH2015-02-13
QIAGEN THERASCREEN EGFR RGQ PCR KIT (P120022/S006)QIAGEN GmbH2015-02-13
COLOGUARD (P130017/S001)Exact Sciences Corporation2015-02-02
THXID-BRAF KIT (P120014/S001)bioMerieux, Inc.2015-01-30
PROGENSA PCA3 ASSAY (P100033/S002)Gen-Probe Incorporated2015-01-21
THERASCREEN KRAS RGQ PCR KIT (P110027/S003)QIAGEN GmbH2015-01-16
THERASCREEN EGFR RGQ PCR KIT (P120022/S005)QIAGEN GmbH2015-01-16
THERASCREEN EGFR RGQ PCR KIT (P120022/S004)QIAGEN GmbH2015-01-15
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S012)Roche Molecular Systems, Inc.2015-01-15
THERASCREEN KRAS RGQ PCR KIT (P110027/S002)QIAGEN GmbH2015-01-15
COBAS EGFR MUTATION TEST (P120019/S005)Roche2015-01-15
THINPREP IMAGING SYSTEM (P020002/S009)Hologic, Inc.2015-01-12
HER2 CISH PHARMDX KIT (P100024/S006)Dako Denmark A/S2014-12-29
THXID BRAF KIT (P120014/S002)bioMerieux, Inc.2014-12-22
BRACANALYSIS CDX (P140020)Myriad Genetic Laboratories2014-12-19
THERASCREEN EGFR RGQ PCR KIT (P120022/S002)QIAGEN GmbH2014-12-19
THINPREP PROCESSORS (P950039/S032)Hologic, Inc.2014-12-10
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S007)Abbott Molecular, Inc.2014-12-10
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S031)Ventana Medical Systems, Inc.2014-12-04
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S016)Ventana Medical Systems, Inc.2014-12-04
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S020)Ventana Medical Systems, Inc.2014-12-04
THINPREP PROCESSORS (P950039/S031)Hologic, Inc.2014-11-20
THINPREP PROCESSORS (P950039/S030)Hologic, Inc.2014-09-26
THINPREP IMAGING SYSTEM (P020002/S008)Hologic, Inc.2014-09-18
THIN PREP PROCESSORS (P950039/S029)Hologic, Inc.2014-09-12
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S008)Abbott Molecular, Inc.2014-08-14
UROVYSION BLADDER CANCER KIT (P030052/S016)Abbott Molecular2014-08-14
COLOGUARD (P130017)Exact Sciences Corporation2014-08-11
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S029)Ventana Medical Systems, Inc.2014-08-06
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S018)Ventana Medical Systems, Inc.2014-07-30
PATH VYSION HER-2 DNA PROBE KIT (P980024/S013)Abbott Molecular, Inc.2014-07-16
URO VYSION BLADDER CANCER KIT (P030052/S015)Abbott Molecular2014-07-16
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S006)Abbott Molecular, Inc.2014-07-16
PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY (P020055/S010)Ventana Medical Systems, Inc.2014-06-13
THERASCREEN KRAS RGQ PCR KIT (P110027)QIAGEN GmbH2014-05-23
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S017)Ventana Medical Systems, Inc.2014-05-06
PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S028)Ventana Medical Systems, Inc.2014-05-06
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S014)Ventana Medical Systems, Inc.2014-05-06
THINPREP IMAGING SYSTEM (P020002/S007)Hologic, Inc.2014-04-29
BD PREPSTAIN SYSTEM (P970018/S028)Bd Diagnostic Systems2014-04-28
THINPREP SLIDES (P950039/S028)Hologic, Inc.2014-04-24
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S016)Ventana Medical Systems, Inc.2014-04-09
PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S027)Ventana Medical Systems, Inc.2014-04-09
COBAS EGFR MUTATION TEST (P120019/S004)Roche2014-03-12
COBAS BRAF V600 MUTATION TEST (P110020/S010)Roche Molecular Systems, Inc.2014-03-12
BD FOCAL POINT SLIDE PROFILER (P950009/S017)Bd Diagnostics2014-02-26
BOND ORACLE HER2 IHC SYSTEM (P090015/S001)Leica Biosystems2014-02-11
THINPREP SLIDES (P950039/S027)Hologic, Inc.2014-01-29
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S004)Abbott Molecular, Inc.2014-01-24
UROVYSION BLADDER CANCER KIT (P030052/S012)Abbott Molecular2014-01-24
PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S026)Ventana Medical Systems, Inc.2014-01-23
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S013)Ventana Medical Systems, Inc.2014-01-23
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S015)Ventana Medical Systems, Inc.2014-01-23
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S014)Ventana Medical Systems, Inc.2014-01-22
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