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Pathology

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

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RecordFirmDate
PATHWAY ANTI-HER-2/NEW (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S025)Ventana Medical Systems, Inc.2014-01-22
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S011)Roche Molecular Systems, Inc.2014-01-09
PATHVYSION HER-2 DNA PROBE KIT (P980024/S012)Abbott Molecular, Inc.2013-12-20
UROVYSION BLADDER CANCER KIT (P030052/S014)Abbott Molecular2013-12-20
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S013)Ventana Medical Systems, Inc.2013-12-16
PATHWAY ANTI-C-KIT (9.7.) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S012)Ventana Medical Systems, Inc.2013-12-16
PATHWAY ANTI-HER2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S024)Ventana Medical Systems, Inc.2013-12-16
BD PREPSTAIN SYSTEM (P970018/S029)Bd Diagnostic Systems2013-12-13
PROGENSA PCA3 ASSAY (P100033/S001)Gen-Probe Incorporated2013-12-12
THE PATH VYSION HER-2 DNA PRODE KIT (P980024/S011)Abbott Molecular, Inc.2013-11-27
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S005)Abbott Molecular, Inc.2013-11-27
URO VYSION BLADDER CANCER KIT (P030052/S013)Abbott Molecular2013-11-27
HERCEPTEST (P980018/S018)Agilent Technologies Singapore (International) Pte , Ltd.2013-11-26
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S023)Ventana Medical Systems, Inc.2013-11-15
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S011)Ventana Medical Systems, Inc.2013-11-15
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S012)Ventana Medical Systems, Inc.2013-11-15
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S020)Ventana Medical Systems, Inc.2013-10-25
BD PREPSTAIN SYSTEM (P970018/S027)Bd Diagnostic Systems2013-10-16
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S011)Ventana Medical Systems, Inc.2013-10-10
PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY (P020055/S009)Ventana Medical Systems, Inc.2013-10-02
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S022)Ventana Medical Systems, Inc.2013-10-02
BD FOCALPOINT SLIDE PROFILER (P950009/S015)Bd Diagnostics2013-09-13
COBAS EGFR MUTATION TEST (P120019/S003)Roche2013-09-12
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S009)Roche Molecular Systems, Inc.2013-09-12
COBAS EGFR MUTATION TEST (P120019/S002)Roche2013-09-06
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S008)Roche Molecular Systems, Inc.2013-09-06
HER2 IQFISH PHARMDX (P040005/S010)Agilent Technologies Singapore (International) Pte , Ltd.2013-08-28
HER2 CISH PHARMDX KIT (P100024/S005)Dako Denmark A/S2013-08-28
PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S021)Ventana Medical Systems, Inc.2013-08-22
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S007)Roche Molecular Systems, Inc.2013-08-21
COBAS EGFR MUTATION TEST (P120019/S001)Roche2013-08-21
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S008)Ventana Medical Systems, Inc.2013-07-25
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S009)Ventana Medical Systems, Inc.2013-07-25
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S019)Ventana Medical Systems, Inc.2013-07-25
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S007)Ventana Medical Systems, Inc.2013-07-23
PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S017)Ventana Medical Systems, Inc.2013-07-23
THERASCREEN EGFR RGQ PCR KIT (P120022)QIAGEN GmbH2013-07-12
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S010)Ventana Medical Systems, Inc.2013-05-29
BIOMERIEUX THXID BRAF ASSAY KIT (P120014)bioMerieux, Inc.2013-05-29
COBAS EGFR MUTATION TEST (P120019)Roche2013-05-14
PATHWAY ANTI-HER-2/NEU (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S018)Ventana Medical Systems, Inc.2013-05-13
INFORM HER2 DUAL ISH DNA PROBE COCTAIL (P100027/S008)Ventana Medical Systems, Inc.2013-05-13
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S007)Ventana Medical Systems, Inc.2013-05-13
HER2 CISH PHARMDX KIT (P100024/S004)Dako Denmark A/S2013-04-19
HERCEPTEST (P980018/S017)Agilent Technologies Singapore (International) Pte , Ltd.2013-04-18
VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES (P110012/S003)Abbott Molecular, Inc.2013-04-17
PATHWAY ANTI-HER-2 (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S016)Ventana Medical Systems, Inc.2013-04-02
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S006)Ventana Medical Systems, Inc.2013-04-02
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S006)Ventana Medical Systems, Inc.2013-04-02
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S005)Ventana Medical Systems, Inc.2013-03-26
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S005)Ventana Medical Systems, Inc.2013-03-20
PATHWAY ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S015)Ventana Medical Systems, Inc.2013-03-20
HER2 FISH PHARMADX KIT (P040005/S009)Agilent Technologies Singapore (International) Pte , Ltd.2013-02-22
HERCAP TEST (P980018/S016)Agilent Technologies Singapore (International) Pte , Ltd.2013-02-22
PATHVYSION HER-2 DNA PROBE KIT (P980024/S010)Abbott Molecular, Inc.2013-02-10
UROVYSION BLADDER CANCER KIT (P030052/S011)Abbott Molecular2013-02-10
ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190 (P110020/S006)Roche Molecular Systems, Inc.2013-01-10
PATHVYSION HER-2 DNA PROBE KIT (P980024/S009)Abbott Molecular, Inc.2012-12-26
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S002)Abbott Molecular, Inc.2012-12-26
PATH VYSION HER-2 DNA PROBE KIT ASSAY (P980024/S007)Abbott Molecular, Inc.2012-12-20
HER2 IQFISH PHARMDX (P040005/S007)Agilent Technologies Singapore (International) Pte , Ltd.2012-12-05
HER2 CISH PHARMDX KIT (P100024/S003)Dako Denmark A/S2012-11-27
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S004)Ventana Medical Systems, Inc.2012-11-21
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S004)Roche Molecular Systems, Inc.2012-11-19
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S004)Ventana Medical Systems, Inc.2012-11-14
PATHWAY ANTI-HER -2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S014)Ventana Medical Systems, Inc.2012-11-14
INFORM HER-2 DUAL DNA PROBE COCKTAIL (P100027/S003)Ventana Medical Systems, Inc.2012-11-14
UROVYSION BLADDER CANCER KIT (P030052/S010)Abbott Molecular2012-11-13
BD PREPSTAIN SYSTEM (P970018/S025)Bd Diagnostic Systems2012-11-08
C-KIT PHARMDX (P040011/S002)Dako North America, Inc.2012-11-02
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S005)Roche Molecular Systems, Inc.2012-09-14
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S003)Roche Molecular Systems, Inc.2012-09-04
BD FOCALPOINT SLIDE PROFILER (P950009/S016)Bd Diagnostics2012-08-30
PATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S012)Ventana Medical Systems, Inc.2012-08-21
UROVYSION BLADDER CANCER KIT ASSAY (P030052/S009)Abbott Molecular2012-08-10
PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S013)Ventana Medical Systems, Inc.2012-08-09
HER2 CISH PHARMDX KIT (P100024/S002)Dako Denmark A/S2012-07-31
HER2 FISH PHARMDX KIT (P040005/S008)Agilent Technologies Singapore (International) Pte , Ltd.2012-07-31
PATHWAY ANTI-C-KIT (9.7) REBBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S003)Ventana Medical Systems, Inc.2012-07-24
PATH VYSION HER-2 DNA PROBE KIT ASSAY (P980024/S008)Abbott Molecular, Inc.2012-07-17
THERASCREEN KRAS RGQ PCR KIT (P110030)QIAGEN Manchester, Ltd.2012-07-06
SPOT-LIGHT HER2 CISH KIT (P050040/S003)Invitrogen Corporation2012-07-06
HER2 FISH PHARMADX KIT (P040005/S006)Agilent Technologies Singapore (International) Pte , Ltd.2012-06-08
HERCEP TEST (P980018/S015)Agilent Technologies Singapore (International) Pte , Ltd.2012-06-08
VYSIS ALK BREAK APART FISH PROBE KIT (P110012/S001)Abbott Molecular, Inc.2012-06-07
TOP2A FISH PHARMADX KIT (P050045/S004)Dako Denmark A/S2012-06-01
BOND ORACLE HER2 IHC SYSTEM (P090015)Leica Biosystems2012-04-18
THINPREP PROCESSOR 2000/3000 SYSTEM (P950039/S024)Hologic, Inc.2012-04-09
BD FOCALPOINT SLIDE PROFILER (P950009/S014)Bd Diagnostics2012-03-09
PATHVYSION HER-2 DNA PROBE KIT (P980024/S006)Abbott Molecular, Inc.2012-02-27
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S002)Ventana Medical Systems, Inc.2012-02-15
PROGENSA PCA3 ASSAY (P100033)Gen-Probe Incorporated2012-02-13
HER2 CISH PHARMADX KIT (P100024/S001)Dako Denmark A/S2012-02-01
REVIEW SCOPE MANUAL (P020002/S006)Hologic, Inc.2012-01-23
HER2 CISH PHARMDX KIT (P100024)Dako Denmark A/S2011-11-30
TOP2A FISH PHARMDX KIT (P050045/S003)Dako Denmark A/S2011-11-10
BD FOCALPOINT SLIDE PROFILER (P950009/S013)Bd Diagnostics2011-11-10
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S002)Roche Molecular Systems, Inc.2011-10-26
ROCHE COBAS 4800 BRAF V600 MUTATION TEST (P110020/S001)Roche Molecular Systems, Inc.2011-10-17
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S001)Ventana Medical Systems, Inc.2011-10-13
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