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Ventana Medical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories11
Latest FDA decision2026-05-15
TypeNumberDevice NameCodeDateActions
PMA P990081 SYSTEM, TEST, HER-2/NEU, IHCMVC2026-05-15 View
PMA P190031 Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancerNYQ2026-05-15 View
PMA P190024 Immunocytochemistry assay, p16/Ki-67QKF2025-09-04 View
PMA P140025 Immunohistochemistry assay, antibody, anaplastic lymphoma kinasePKW2025-06-20 View
PMA P020055 Immunohistochemistry antibody assay, c-kitNKF2025-06-20 View
PMA P160046 Immunohistochemistry assay, antibody, programmed death-ligand 1PLS2025-06-20 View
PMA P220006 Immunohistochemistry Assay, Antibody, FOLR1QUL2025-06-20 View
PMA P230018 Immunohistochemistry assay, antibody, claudin 18QZJ2025-06-20 View
510(k) K242783 Roche Digital Pathology DxPSY2024-12-17 View
510(k) K232879 Roche Digital Pathology Dx (VENTANA DP 200)PSY2024-06-14 View
PMA P160002 Immunohistochemistry assay, antibody, programmed death-ligand 1PLS2024-04-01 View
PMA P100027 Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancerNYQ2024-01-26 View
510(k) K212176 CINtec HistologyPRB2021-12-10 View
510(k) K172471 VENTANA CD30 (Ber-H2) RxDx AssayDEH2018-05-08 View
PMA P160006 Immunohistochemistry assay, antibody, programmed death-ligand 1PLS2016-10-18 View
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