Medical Device Manufacturer · US , Tucson , AZ

Ventana Medical Systems, Inc.

48 submissions · 46 cleared · Since 1992
48
Total
46
Cleared
2
Denied

Ventana Medical Systems, Inc. — FDA 510(k) Submissions

Ventana Medical Systems, Inc. has submitted 48 FDA 510(k) premarket notifications since 1992, of which 46 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lambda, Antigen, Antiserum, Control, Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity, Alpha-1-antitrypsin, Antigen, Antiserum, Control, NOT, Igm, Peroxidase, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

48 devices
1–25 of 48
Roche Digital Pathology Dx
K242783 · PSY Whole Slide Imaging System · Pathology
Dec 2024 92d
VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
DEN240025 · SDP Kappa And Lambda... · Pathology
Dec 2024 190d
Roche Digital Pathology Dx (VENTANA DP 200)
K232879 · PSY Whole Slide Imaging System · Pathology
Jun 2024 270d
CINtec Histology
K212176 · PRB Cervical Intraepithelial... · Pathology
Dec 2021 151d
VENTANA CD30 (Ber-H2) RxDx Assay
K172471 · DEH Lambda, Antigen,... · Medical Genetics
May 2018 266d
CINtec Histology (50 tests), CINtec Histology (250 tests)
DEN160019 · PRB Cervical Intraepithelial... · Pathology
Mar 2017 285d
Virtuoso System for IHC PR (1E2) using iScan HT
K142965 · OEO Automated Digital Image... · Pathology
Jul 2015 275d
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
K140465 · NQN Microscope, Automated,... · Pathology
Mar 2014 24d
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515 · NQN Microscope, Automated,... · Pathology
Nov 2013 268d
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516 · NQN Microscope, Automated,... · Pathology
Sep 2013 492d
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · NQN Microscope, Automated,... · Pathology
Sep 2013 427d
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K121033 · NOT · Pathology
Sep 2013 519d
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
K110215 · MYA Immunohistochemistry... · Pathology
Dec 2012 719d
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · NOT · Pathology
Jun 2012 28d
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · NQN Microscope, Automated,... · Pathology
Apr 2012 293d
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · NQN Microscope, Automated,... · Pathology
Mar 2012 248d
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K111755 · NOT · Pathology
Feb 2012 245d
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
K111543 · NOT · Pathology
Oct 2011 132d
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
K101234 · OWF Immunohistochemical... · Microbiology
Aug 2011 479d
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · MXZ Immunohistochemistry... · Pathology
Jul 1999 148d
VENTANA CD45 PRIMARY ANTIBODY
K940583 · DEH Lambda, Antigen,... · Immunology
Oct 1997 1350d
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389 · DEM Alpha-1-antitrypsin,... · Immunology
Oct 1997 85d
CHEMMATE L26 (CD20)
K973390 · DEM Alpha-1-antitrypsin,... · Immunology
Oct 1997 85d
CHEMMATE KAPPA
K973391 · DEM Alpha-1-antitrypsin,... · Immunology
Oct 1997 85d
CHEMMATE LAMBDA
K973392 · DEM Alpha-1-antitrypsin,... · Immunology
Oct 1997 86d
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