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Ventana Medical Systems, Inc.

FDA 510(k) & PMA Approved Devices — 44 products

Total Devices44
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K242783 Roche Digital Pathology DxPSY2024-12-17 View
510(k) K232879 Roche Digital Pathology Dx (VENTANA DP 200)PSY2024-06-14 View
510(k) K212176 CINtec HistologyPRB2021-12-10 View
510(k) K172471 VENTANA CD30 (Ber-H2) RxDx AssayDEH2018-05-08 View
510(k) K130515 VIRTUOSO SYSTEM FOR IHC ER (SPI)NQN2013-11-22 View
510(k) K121516 VIRTUOSO SYSTEM FOR IHC HER2 (4B5)NQN2013-09-26 View
510(k) K122143 VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINERNQN2013-09-19 View
510(k) K121033 VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)NOT2013-09-06 View
510(k) K110215 CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYMYA2012-12-17 View
510(k) K121350 VIRTUSO SYSTEM FOR IHC (DO-7)NOT2012-06-01 View
510(k) K111872 VIRTUOSO SYSTEM FOR IHC P53 (DO-7)NQN2012-04-19 View
510(k) K111869 VIRTUOSO SYSTEM FOR IHC PR (IE2)NQN2012-03-05 View
510(k) K111755 VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)NOT2012-02-22 View
510(k) K111543 VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)NOT2011-10-12 View
510(k) K101234 VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYOWF2011-08-25 View
510(k) K990618 VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)MXZ1999-07-23 View
510(k) K940583 VENTANA CD45 PRIMARY ANTIBODYDEH1997-10-20 View
510(k) K973389 CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAININGDEM1997-10-03 View
510(k) K973390 CHEMMATE L26 (CD20)DEM1997-10-03 View
510(k) K973391 CHEMMATE KAPPADEM1997-10-03 View
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