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Ventana Medical Systems, Inc.

237 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059)Ventana Medical Systems, Inc.2025-12-15
HER2 Dual ISH DNA Probe Cocktail (P190031/S014)Ventana Medical Systems, Inc.2025-12-15
CINtec PLUS Cytology (P190024/S015)Ventana Medical Systems, Inc.2025-09-04
CINtec PLUS Cytology (P190024/S014)Ventana Medical Systems, Inc.2025-07-31
VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001)Ventana Medical Systems, Inc.2025-06-20
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057)Ventana Medical Systems, Inc.2025-06-20
VENTANA ALK (D5F3) CDX ASSAY (P140025/S025)Ventana Medical Systems, Inc.2025-06-20
VENTANA PD-L1 (SP263) ASSAY (P160046/S020)Ventana Medical Systems, Inc.2025-06-20
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006/S007)Ventana Medical Systems, Inc.2025-06-20
PATHWAY® Anti-c-KIT (9.7) Primary Antibody (P020055/S032)Ventana Medical Systems, Inc.2025-06-20
VENTANA HER2 DualL ISH DNA Probe Cocktail (P190031/S013)Ventana Medical Systems, Inc.2025-06-16
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S056)Ventana Medical Systems, Inc.2025-06-11
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S012)Ventana Medical Systems, Inc.2025-05-16
CINtec PLUS Cytology (P190024/S013)Ventana Medical Systems, Inc.2025-04-25
VENTANA ALK (D5F3) CDx Assay (P140025/S024)Ventana Medical Systems, Inc.2025-03-12
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S055)Ventana Medical Systems, Inc.2025-01-27
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S006)Ventana Medical Systems, Inc.2025-01-08
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S054)Ventana Medical Systems, Inc.2024-11-20
VENTANA PD-L1 (SP263) CDx Assay (P160046/S019)Ventana Medical Systems, Inc.2024-10-23
VENTANA CLDN18 (43-14A) RxDx Assay (P230018)Ventana Medical Systems, Inc.2024-10-18
VENTANA PD-L1(SP142) Assay (P160002/S024)Ventana Medical Systems, Inc.2024-04-01
VENTANA ALK (D5F3) CDx Assay (P140025/S023)Ventana Medical Systems, Inc.2024-01-26
CINtec PLUS Cytology (P190024/S012)Ventana Medical Systems, Inc.2024-01-26
VENTANA PD-Ll (SP263) Assay (P160046/S018)Ventana Medical Systems, Inc.2024-01-26
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S053)Ventana Medical Systems, Inc.2024-01-26
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S010)Ventana Medical Systems, Inc.2024-01-26
VENTANA PD-Ll (SP142) Assay (P160002/S023)Ventana Medical Systems, Inc.2024-01-26
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S031)Ventana Medical Systems, Inc.2024-01-26
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S041)Ventana Medical Systems, Inc.2024-01-26
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006/S005)Ventana Medical Systems, Inc.2024-01-26
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S052)Ventana Medical Systems, Inc.2023-11-08
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S009)Ventana Medical Systems, Inc.2023-11-08
VENTANA PD-Ll (SP142) Assay (P160002/S022)Ventana Medical Systems, Inc.2023-11-08
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S040)Ventana Medical Systems, Inc.2023-11-08
VENTANA PD-Ll (SP263) Assay (P160046/S017)Ventana Medical Systems, Inc.2023-11-08
VENTANA ALK (D5F3) CDx Assay (P140025/S022)Ventana Medical Systems, Inc.2023-11-08
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S030)Ventana Medical Systems, Inc.2023-11-08
CINtec PLUS Cytology (P190024/S011)Ventana Medical Systems, Inc.2023-11-08
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S004)Ventana Medical Systems, Inc.2023-11-08
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S002)Ventana Medical Systems, Inc.2023-08-29
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S008)Ventana Medical Systems, Inc.2023-08-29
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S039)Ventana Medical Systems, Inc.2023-08-29
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S051)Ventana Medical Systems, Inc.2023-08-29
VENTANA PD-Ll (SP263) Assay (P160046/S016)Ventana Medical Systems, Inc.2023-08-29
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S029)Ventana Medical Systems, Inc.2023-08-29
VENTANA ALK (D5F3) CDx Assay (P140025/S021)Ventana Medical Systems, Inc.2023-08-29
VENTANA PD-Ll (SP142) Assay (P160002/S021)Ventana Medical Systems, Inc.2023-08-29
CINtec PLUS Cytology (P190024/S010)Ventana Medical Systems, Inc.2023-08-29
VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S001)Ventana Medical Systems, Inc.2023-08-23
VENTANA PD-L1 (SP263) Assay (P160046/S013)Ventana Medical Systems, Inc.2023-03-01
VENTANA PD-L1 (SP142) Assay (P160002/S020)Ventana Medical Systems, Inc.2023-02-07
CINtec PLUS Cytology (P190024/S009)Ventana Medical Systems, Inc.2023-01-30
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006)Ventana Medical Systems, Inc.2022-11-14
CINtec PLUS Cytology (P190024/S008)Ventana Medical Systems, Inc.2022-11-10
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S050)Ventana Medical Systems, Inc.2022-11-10
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S028)Ventana Medical Systems, Inc.2022-11-10
VENTANA ALK (D5F3) CDx Assay (P140025/S020)Ventana Medical Systems, Inc.2022-11-10
VENTANA PD-L1 (SP263) Assay (P160046/S015)Ventana Medical Systems, Inc.2022-11-10
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S038)Ventana Medical Systems, Inc.2022-11-10
VENTANA PD-L1 (SP142) Assay (P160002/S019)Ventana Medical Systems, Inc.2022-11-10
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S007)Ventana Medical Systems, Inc.2022-11-10
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S047)Ventana Medical Systems, Inc.2022-09-30
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S037)Ventana Medical Systems, Inc.2022-07-29
CINtec PLUS Cytology (P190024/S007)Ventana Medical Systems, Inc.2022-07-29
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S005)Ventana Medical Systems, Inc.2022-07-29
VENTANA ALK (D5F3) CDx Assay (P140025/S018)Ventana Medical Systems, Inc.2022-07-29
VENTANA PD-L1 (SP142) Assay (P160002/S018)Ventana Medical Systems, Inc.2022-07-29
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S027)Ventana Medical Systems, Inc.2022-07-29
VENTANA PD-L1 (SP263) Assay (P160046/S014)Ventana Medical Systems, Inc.2022-07-29
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S048)Ventana Medical Systems, Inc.2022-07-29
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S004)Ventana Medical Systems, Inc.2022-07-21
VENTANA ALK (D5F3) CDx Assay (P140025/S017)Ventana Medical Systems, Inc.2022-07-21
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S036)Ventana Medical Systems, Inc.2022-07-21
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S046)Ventana Medical Systems, Inc.2022-07-21
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S026)Ventana Medical Systems, Inc.2022-07-21
VENTANA PD-Ll (SP263) Assay (P160046/S012)Ventana Medical Systems, Inc.2022-07-21
CINtec PLUS Cytology (P190024/S006)Ventana Medical Systems, Inc.2022-07-21
VENTANA PD-Ll (SP142) Assay (P160002/S017)Ventana Medical Systems, Inc.2022-07-21
VENTANA ALK (D5F3) CDx Assay (P140025/S016)Ventana Medical Systems, Inc.2022-06-10
VENTANA PD-L1 (SP263) Assay (P160046/S011)Ventana Medical Systems, Inc.2022-06-10
VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S003)Ventana Medical Systems, Inc.2022-06-10
CINtec PLUS Cytology (P190024/S005)Ventana Medical Systems, Inc.2022-06-10
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S045)Ventana Medical Systems, Inc.2022-06-10
VENTANA PD-L1(SP142) Assay (P160002/S016)Ventana Medical Systems, Inc.2022-06-10
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S035)Ventana Medical Systems, Inc.2022-06-10
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S025)Ventana Medical Systems, Inc.2022-06-10
VENTANA PD-L1 (SP263) Assay (P160046/S010)Ventana Medical Systems, Inc.2021-10-15
VENTANA PD-L1 (SP142) Assay (P160002/S015)Ventana Medical Systems, Inc.2021-09-28
VENTANA HER2 Dual ISI-I DNA Probe Cocktail (P190031/S002)Ventana Medical Systems, Inc.2021-05-20
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S044)Ventana Medical Systems, Inc.2021-05-20
VENTANA PD-LI (SP142) Assay (P160002/S014)Ventana Medical Systems, Inc.2021-05-20
PATI-IWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S024)Ventana Medical Systems, Inc.2021-05-20
VENTANA PD-LI (SP263) Assay (P160046/S009)Ventana Medical Systems, Inc.2021-05-20
VENTANA ALK (D5F3) CDx Assay (P140025/S015)Ventana Medical Systems, Inc.2021-05-20
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S034)Ventana Medical Systems, Inc.2021-05-20
CINtec PLUS Cytology (P190024/S003)Ventana Medical Systems, Inc.2021-05-20
CINtec PLUS Cytology (P190024/S004)Ventana Medical Systems, Inc.2021-03-29
VENTANA ALK (D5F3) CDx Assay (P140025/S014)Ventana Medical Systems, Inc.2021-03-03
PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S023)Ventana Medical Systems, Inc.2020-11-13
INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S033)Ventana Medical Systems, Inc.2020-11-13
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Every clearance here is in the API, with alerts when new ones post.