FDA 510(k) Applications Submitted by Ventana Medical Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K130515 02/27/2013 VIRTUOSO SYSTEM FOR IHC ER (SPI) VENTANA MEDICAL SYSTEMS, INC.
K121033 04/05/2012 VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) VENTANA MEDICAL SYSTEMS, INC.
K121350 05/04/2012 VIRTUSO SYSTEM FOR IHC (DO-7) VENTANA MEDICAL SYSTEMS, INC.
K121516 05/22/2012 VIRTUOSO SYSTEM FOR IHC HER2 (4B5) VENTANA MEDICAL SYSTEMS, INC.
K122143 07/19/2012 VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER VENTANA MEDICAL SYSTEMS, INC.
K111543 06/02/2011 VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) VENTANA MEDICAL SYSTEMS, INC.
K172471 08/15/2017 VENTANA CD30 (Ber-H2) RxDx Assay Ventana Medical Systems, Inc.
K990618 02/25/1999 VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) VENTANA MEDICAL SYSTEMS, INC.
K101234 05/03/2010 VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K940242 01/19/1994 VENTANA CEA PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K940331 01/24/1994 KERATIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K973393 07/01/1997 CHEMMATE LCA VENTANA MEDICAL SYSTEMS, INC.
K973392 07/09/1997 CHEMMATE LAMBDA VENTANA MEDICAL SYSTEMS, INC.
K973389 07/10/1997 CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING VENTANA MEDICAL SYSTEMS, INC.
K973390 07/10/1997 CHEMMATE L26 (CD20) VENTANA MEDICAL SYSTEMS, INC.
K973391 07/10/1997 CHEMMATE KAPPA VENTANA MEDICAL SYSTEMS, INC.
K940583 02/08/1994 VENTANA CD45 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941707 04/06/1994 ANTI-MUSCLE ACTIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K140465 02/24/2014 VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER VENTANA MEDICAL SYSTEMS, INC.
K142965 10/14/2014 Virtuoso System for IHC PR (1E2) using iScan HT Ventana Medical Systems, Inc.
K110215 12/29/2010 CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K212176 07/12/2021 CINtec Histology Ventana Medical Systems, Inc.
K941170 03/14/1994 VENTANA ANTI-MELANOMA PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941514 03/29/1994 VENTANA ANTI-S100 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941782 04/11/1994 VENTANA ANTI-CD5 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941784 04/11/1994 VENTANA ANTI-CD8 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K935161 10/29/1993 KERATIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941173 03/14/1994 ANTI-KERATIN-HMW PRIMARY ANTI-BODY VENTANA MEDICAL SYSTEMS, INC.
K941397 03/22/1994 ANTI-VIMENTIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941505 03/29/1994 VENTANNA ANTI-CD3 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941604 04/01/1994 VENTANA ANTI-CD4 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K941516 03/29/1994 VENTANNA ANTI-DESMIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC.
K111755 06/22/2011 VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) VENTANA MEDICAL SYSTEMS, INC.
K111869 07/01/2011 VIRTUOSO SYSTEM FOR IHC PR (IE2) VENTANA MEDICAL SYSTEMS, INC.
K111872 07/01/2011 VIRTUOSO SYSTEM FOR IHC P53 (DO-7) VENTANA MEDICAL SYSTEMS, INC.


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