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Pathology

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

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RecordFirmDate
PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY (P020055/S002)Ventana Medical Systems, Inc.2011-09-27
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S011)Ventana Medical Systems, Inc.2011-09-27
PREPSTAIN SYSTEM/PREPMATE (P970018/S024)Bd Diagnostic Systems2011-09-21
HERCEPTEST (P980018/S014)Agilent Technologies Singapore (International) Pte , Ltd.2011-09-09
PATHWAY ANTI-HER-2/NEU (4B5) RABBITT MONOCLONAL PRIMARY ANTIBODY (P990081/S010)Ventana Medical Systems, Inc.2011-09-06
VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK (P110012)Abbott Molecular, Inc.2011-08-26
COBAS 4800 BRAF V600 MUTATION TEST (P110020)Roche Molecular Systems, Inc.2011-08-17
URO VYSION BLADDER CANCER KIT ASSAY (P030052/S008)Abbott Molecular2011-07-20
BD PREPSTAIN SYSTEM VACUUM PUMP SAFETY HAZARD (P970018/S023)Bd Diagnostic Systems2011-07-15
SPOT-LIGHT HER2 CISH KIT (P050040/S001)Invitrogen Corporation2011-07-12
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027)Ventana Medical Systems, Inc.2011-06-14
UROVYSION BLADDER CANCER KIT ASSAY (P030052/S007)Abbott Molecular2011-06-01
UROVYSION BLADDER CANCER KIT (P030052/S006)Abbott Molecular2011-05-26
SPOT-LIGHT HER2 CISH KIT (P050040/S002)Invitrogen Corporation2011-04-29
PATHVYSION HER-2 DNA PROBE KIT (P980024/S005)Abbott Molecular, Inc.2011-04-18
HERCEPTEST (P980018/S013)Agilent Technologies Singapore (International) Pte , Ltd.2011-04-18
UROVYSION BLADDER CANCER KIT (P030052/S005)Abbott Molecular2011-04-08
UROVYSION BLADDER CANCER KIT (P030052/S004)Abbott Molecular2011-03-22
HERCEPTEST KIT (P980018/S011)Agilent Technologies Singapore (International) Pte , Ltd.2011-02-17
HERCEPTEST (P980018/S012)Agilent Technologies Singapore (International) Pte , Ltd.2011-02-11
PATHVYSION HER-2 DNA PROBE KIT (P980024/S004)Abbott Molecular, Inc.2011-01-10
PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S008)Ventana Medical Systems, Inc.2010-11-17
HERCEPTEST (P980018/S010)Agilent Technologies Singapore (International) Pte , Ltd.2010-10-20
HER2 FISH PHARMDX KIT (P040005/S005)Agilent Technologies Singapore (International) Pte , Ltd.2010-10-20
HERCEPTEST KIT (P980018/S009)Agilent Technologies Singapore (International) Pte , Ltd.2010-10-07
BD FOCALPOINT GS IMAGING SYSTEM (P950009/S012)Bd Diagnostics2010-09-16
THINPREP IMAGING SYSTEM LABELING (P020002/S005)Hologic, Inc.2010-09-16
PREPSTAIN SYSTEM (P970018/S021)Bd Diagnostic Systems2010-06-30
HER2 FISH PHARMDX KIT (P040005/S004)Agilent Technologies Singapore (International) Pte , Ltd.2010-06-29
BD PREPSTAIN SYSTEM (P970018/S018)Bd Diagnostic Systems2010-04-02
THINPREP PROCESSOR 2000/3000 (P950039/S021)Hologic, Inc.2010-03-18
BD FOCALPOINT GS IMAGING SYSTEM (P950009/S010)Bd Diagnostics2010-03-15
PREPSTAIN INSTRUMENT (P970018/S019)Bd Diagnostic Systems2010-03-11
BD PREPSTAIN SYSTEM (P970018/S020)Bd Diagnostic Systems2010-03-08
HERCEPTEST (P980018/S008)Agilent Technologies Singapore (International) Pte , Ltd.2010-03-08
HERCEP TEST (P980018/S006)Agilent Technologies Singapore (International) Pte , Ltd.2010-02-25
HERCEPTEST (P980018/S007)Agilent Technologies Singapore (International) Pte , Ltd.2010-01-21
BD FOCALPOINT SLIDE PROFILER (P950009/S011)Bd Diagnostics2010-01-08
GENESEARCH BREAST LYMPH NODE (BLN) ASSAY (P060017/S004)Janssen Diagnostics2009-12-17
BD PREPSTAIN SYSTEM (P970018/S017)Bd Diagnostic Systems2009-11-16
THINPREP PROCESSOR 2000/3000 (P950039/S020)Hologic, Inc.2009-10-02
BD FOCALPOINT SYSTEM (P950009/S009)Bd Diagnostics2009-07-24
PREPSTAIN SYSTEM (P970018/S015)Bd Diagnostic Systems2009-07-24
GENESEARCH BREAST LYMPH NODE ASSAY (P060017/S003)Janssen Diagnostics2009-07-09
PREPSTAIN SYSTEM (P970018/S016)Bd Diagnostic Systems2009-07-02
UROVYSION BLADDER CANCER KIT (P030052/S003)Abbott Molecular2009-02-25
PATHVYSION HER-2 DNA PROBE KIT (P980024/S003)Abbott Molecular, Inc.2009-02-10
BD FOCALPOINT GS IMAGING SYSTEM (P950009/S008)Bd Diagnostics2008-12-03
PREPSTAIN SYSTEM (P970018/S014)Bd Diagnostic Systems2008-11-07
MONOPREP PAP TEST (P040052/S008)Hologic, Inc.2008-10-16
HER2FISH PHARMDX KIT (P040005/S003)Agilent Technologies Singapore (International) Pte , Ltd.2008-10-10
MONOPREP PAP TEST (P040052/S007)Hologic, Inc.2008-10-01
MONOPREP PAP TEST (P040052/S005)Hologic, Inc.2008-08-11
MONOPREP PAP TEST (P040052/S006)Hologic, Inc.2008-07-09
SPOT-LIGHT HER2 CISH KIT (P050040)Invitrogen Corporation2008-07-01
TOP2A FISH PHARMDX (P050045/S002)Dako Denmark A/S2008-03-26
HER2 FISH PHARMDX KIT (P040005/S002)Agilent Technologies Singapore (International) Pte , Ltd.2008-02-13
TOP2A FISH PHARMDX KIT (P050045/S001)Dako Denmark A/S2008-02-13
DAKO TOP2A FISH PHARMDX KIT (P050045)Dako Denmark A/S2008-01-11
MONOPREP PAP TEST (P040052/S001)Hologic, Inc.2007-12-14
PATHWAY ANTI-HER-2/NEU (P990081/S007)Ventana Medical Systems, Inc.2007-12-12
GENESEARCH BREAST LYMPH NODE (P060017/S001)Janssen Diagnostics2007-10-23
MONOPREP PAP TEST (P040052/S004)Hologic, Inc.2007-08-31
THINPREP 2000 SYSTEM (P950039/S018)Hologic, Inc.2007-08-30
THINPREP IMAGING SYSTEM (P020002/S003)Hologic, Inc.2007-08-30
PATHWAY HER-2/NEU CONTROL SLIDES (P990081/S006)Ventana Medical Systems, Inc.2007-07-24
GENESEARCH BREAST LYMPH NODE(BLN) ASSAY (P060017)Janssen Diagnostics2007-07-16
MONOPREP PAP TEST (P040052/S002)Hologic, Inc.2007-05-25
PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (P020055/S001)Ventana Medical Systems, Inc.2007-05-16
PREPSTAIN SYSTEM (P970018/S012)Bd Diagnostic Systems2007-05-09
DAKO C-KIT PHARMDX (P040011/S001)Dako North America, Inc.2007-04-23
VENTANNA PATHWAY HER-2 (CLONE CB11) (P990081/S005)Ventana Medical Systems, Inc.2007-04-11
UROVYSION BLADDER CANCER KIT (P030052/S002)Abbott Molecular2007-02-06
PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY (P990081/S003)Ventana Medical Systems, Inc.2007-01-11
THINPREP 2000 SYSTEM (P950039/S017)Hologic, Inc.2006-10-05
DAKO EGFR PHARMDX KIT (P030044/S002)Agilent Technologies, Inc.2006-09-27
PATHWAY HER-2/NEU (CLONE CB11) PRIMARY ANTIBODY (P990081/S004)Ventana Medical Systems, Inc.2006-09-05
UROVYSION BLADDER CANCER KIT (P030052/S001)Abbott Molecular2006-05-10
VYSIS PATH VYSION HER-2 DNA PROBE KIT (P980024/S002)Abbott Molecular, Inc.2006-05-10
THINPREP IMAGING SYSTEM (P020002/S002)Hologic, Inc.2006-04-28
HER2 FISH PHARMDX KIT (P040005/S001)Agilent Technologies Singapore (International) Pte , Ltd.2006-04-21
MONOPREP PAP TEST (P040052)Hologic, Inc.2006-03-03
DAKOCYTOMATION EGFR PHARMDX KIT (P030044/S001)Agilent Technologies, Inc.2006-02-01
THINPREP 2000 SYSTEM (P950039/S016)Hologic, Inc.2006-01-18
HERCEPTEST (P980018/S003)Agilent Technologies Singapore (International) Pte , Ltd.2005-12-30
HERCEP TEST (P980018/S005)Agilent Technologies Singapore (International) Pte , Ltd.2005-12-30
PATHWAY HER-2/NEU (CLONE CD11) PRIMARY ANTIBODY (P990081/S002)Ventana Medical Systems, Inc.2005-10-21
PREPSTAIN SYSTEM (P970018/S010)Bd Diagnostic Systems2005-09-28
THINPREP 2000 SYSTEM (P950039/S015)Hologic, Inc.2005-09-28
THINPREP 2000 SYSTEM (P950039/S012)Hologic, Inc.2005-08-05
HERCEP TEST (P980018/S004)Agilent Technologies Singapore (International) Pte , Ltd.2005-07-13
C-KIT PHARMDX (P040011)Dako North America, Inc.2005-06-27
THINPREP IMAGING SYSTEM (P020002/S001)Hologic, Inc.2005-06-08
DAKOCYTOMATION HER2 FISH PHARMDX KIT (P040005)Agilent Technologies Singapore (International) Pte , Ltd.2005-05-03
THINPREP 2000 SYSTEM (P950039/S014)Hologic, Inc.2005-03-18
PREPSTAIN SYSTEM (P970018/S009)Bd Diagnostic Systems2005-02-11
UROVYSION BLADDER CANCER KIT (P030052)Abbott Molecular2005-01-24
INSITE HER-2/NEU KIT (P040030)Biogenex Laboratories, Inc.2004-12-22
THINPREP 2000 SYSTEM (P950039/S013)Hologic, Inc.2004-12-06
VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY (P020055)Ventana Medical Systems, Inc.2004-08-11
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