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Ventana Medical Systems, Inc.

237 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VENTANA PD-L1 (SP142) Assay (P160002/S013)Ventana Medical Systems, Inc.2020-11-13
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S001)Ventana Medical Systems, Inc.2020-11-13
VENTANA ALK (D5F3) CDx Assay (P140025/S013)Ventana Medical Systems, Inc.2020-11-13
VENTANA PD-L1 (SP263) Assay (P160046/S008)Ventana Medical Systems, Inc.2020-11-13
CINtec PLUS Cytology (P190024/S002)Ventana Medical Systems, Inc.2020-11-13
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S043)Ventana Medical Systems, Inc.2020-11-13
CINtec PLUS Cytology (P190024/S001)Ventana Medical Systems, Inc.2020-08-14
HER2 Dual ISH DNA Probe Cocktail (P190031)Ventana Medical Systems, Inc.2020-07-28
Ventana PD-L1 (SP142) Assay (P160002/S012)Ventana Medical Systems, Inc.2020-05-18
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S042)Ventana Medical Systems, Inc.2020-03-31
VENTANA PD-L1(SP142) Assay (P160002/S011)Ventana Medical Systems, Inc.2020-03-31
VENTANA PD-L1 (SP263) Assay (P160046/S007)Ventana Medical Systems, Inc.2020-03-31
VENTANA ALK (D5F3) CDx Assay (P140025/S012)Ventana Medical Systems, Inc.2020-03-31
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S032)Ventana Medical Systems, Inc.2020-03-31
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S022)Ventana Medical Systems, Inc.2020-03-31
CINtec PLUS Cytology (P190024)Ventana Medical Systems, Inc.2020-03-10
Ventana PD-Ll (SP263) Assay (P160046/S006)Ventana Medical Systems, Inc.2019-11-19
Inform HER2 Dual ISH DNA Probe Cocktail (P100027/S031)Ventana Medical Systems, Inc.2019-11-19
Ventana PD-Ll (SP142) Assay (P160002/S010)Ventana Medical Systems, Inc.2019-11-19
Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S041)Ventana Medical Systems, Inc.2019-11-19
Ventana ALK (D5F3) CDx Assay (P140025/S011)Ventana Medical Systems, Inc.2019-11-19
PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody (P990081/S040)Ventana Medical Systems, Inc.2019-05-06
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S039)Ventana Medical Systems, Inc.2019-05-03
INFORM HER2 Dual ISH DNA Probe Cocktail assays (P100027/S030)Ventana Medical Systems, Inc.2019-05-03
VENTANA PD-L1(SP142) Assay. (P160002/S009)Ventana Medical Systems, Inc.2019-03-08
Ventana ALK (D5f3) CDx Assay (P140025/S010)Ventana Medical Systems, Inc.2018-12-07
VENTANA PD-L1 (SP263) Assay (P160046/S005)Ventana Medical Systems, Inc.2018-09-13
VENTANA PD-L1(SP142) Assay (P160002/S007)Ventana Medical Systems, Inc.2018-09-13
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S029)Ventana Medical Systems, Inc.2018-09-13
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S038)Ventana Medical Systems, Inc.2018-09-13
VENTANA ALK (D5F3) CDx Assay (P140025/S009)Ventana Medical Systems, Inc.2018-09-13
VENTANA PD-L1(SP142) CDX ASSAY (P160002/S006)Ventana Medical Systems, Inc.2018-07-02
Ventana PD-L1 (SP263) (P160046/S004)Ventana Medical Systems, Inc.2018-06-01
VENTANA ALK (D5F3) CDx Assay (P140025/S006)Ventana Medical Systems, Inc.2017-11-06
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
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
VENTANA PD-L1 (SP263) ASSAY (P160046)Ventana Medical Systems, Inc.2017-05-01
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
VENTANA PD-L1(SP142) CDX ASSAY (P160002/S001)Ventana Medical Systems, Inc.2016-12-21
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S025)Ventana Medical Systems, Inc.2016-11-30
VENTANA ALK (D5F3) CDX ASSAY (P140025/S003)Ventana Medical Systems, Inc.2016-10-21
VENTANA PD-L1 (SP142) Assay (P160006)Ventana Medical Systems, Inc.2016-10-18
VENTANA PD-L1(SP142) CDX ASSAY (P160002)Ventana Medical Systems, Inc.2016-05-18
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
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
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
VENTANA ALK (D5F3) CDX ASSAY (P140025)Ventana Medical Systems, Inc.2015-06-12
INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S021)Ventana Medical Systems, Inc.2015-03-19
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
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY (P020055/S015)Ventana Medical Systems, Inc.2015-02-19
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
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
PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY (P020055/S010)Ventana Medical Systems, Inc.2014-06-13
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
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
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
PATHWAY ANTI-HER-2/NEW (4B5)RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S025)Ventana Medical Systems, Inc.2014-01-22
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
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
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
PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081/S021)Ventana Medical Systems, Inc.2013-08-22
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
INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL (P100027/S010)Ventana Medical Systems, Inc.2013-05-29
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